Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1319721

FEI Number

1000159913

Entity Name

REICHERT INC.

City/State/Country

DEPEW, NY, US

Establishment Address

3362 Walden Ave, Suite 100, DEPEW, NY 14043, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

REICHERT INC. (Owner Number: 9055850)

Owner / Operator Contact Address

3362 WALDEN AVE., Suite 100, Depew, NY 14043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ocu-Film® + CATS Tonometer Prism UNISTAT® Bilirubinometer Xcel® 455 Slit Lamp A900 Tonometer Quebec® Digital Darkfield Colony Counter LensChek Pro Digital Lensometer® LensChek Plus Digital Lensometer® CT210 Contact Tonometer iPac® Pachymeter Reichert Digital USG-Chek Goldberg TS Meter Reichert Digital Clinic-Chek Reichert Digital VET360-Chek Reichert VET 360 TS Meter Model 30 Tip and Membrane Assembly for Pneumatonometer PSL Portable Slit Lamp Ocular Response Analyzer Ocular Response Analyzer® G3 Refractix DSP TS Meter DSP Phoroptor® VRx Phoroptor® VRx with Prism Illuminated Phoroptor® Ultramatic RX Master Phoroptor® SightChek® Digital Phoroptor ACTIVA MED Reichert® 7CR Auto Tonometer + Corneal Response Technology® Ocular Response Analyzer® Tono-Pen AVIA Vet® Tono-Pen AVIA® TF50 Trial Frame Model 30 Pneumatonometer Xcel® 255 Slit Lamp Tono-Vera® Tonometer Starter Kit, Rechargeable Tono-Vera® Tonometer Starter Kit, AA Battery Ocu-Dot® Tonometer Probes - 100 Count CP-M Circular Polarizer NearBright Illuminated Near Vision Kit ClearChart® 4X AcuityChek ClearChart® 4 CP-D Circular Polarizer ClearChart® 4P TS75 Trial Lens Set Quebec® Manual Darkfield Colony Counter OS1000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2007-11-14
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2020-03-10
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2007-11-14
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2014-11-06
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2013-12-05
KZB	Automated Colony Counter	Microbiology	Class 1	866.2170	2012-12-14
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	1996-05-23
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2007-11-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2007-11-14
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2004-06-17
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2007-11-14
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	1995-05-09
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	1996-05-23
PSM	Refractometer For Donor Testing	Clinical Chemistry	Class 1	862.2800	2019-03-26
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	1996-05-23
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-03-27
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2010-11-12
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2007-11-14
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2006-09-18
HKX	Tonometer, Ac-Powered	Ophthalmic	Class 2	886.1930	2007-11-14
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2007-11-14
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2024-05-08
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2012-12-04
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2006-09-18
KZC	Manual Colony Counter	Microbiology	Class 1	866.2180	2004-06-23
MMQ	Topographer, Corneal, Ac-Powered	Ophthalmic	Class 1	886.1350	2006-09-18

Official Correspondent

Richard Boerdner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

REICHERT INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002894792	AMETEK Lamb Motores de Mexico, S. de R.L. de C.V.	Reynosa Tamaulipas, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K980646	Instrumentation Laboratory CO	IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES	1998-05-06
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319721. Last updated year: 2026. Please use registration number 1319721 when referencing this establishment in official correspondence.