Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007135420

FEI Number

3007135420

Entity Name

Carclo Technical Plastics - Latrobe

City/State/Country

Latrobe, PA, US

Establishment Address

550 & 600 Depot St, Latrobe, PA 15650, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CARCLO TECHNICAL PLASTICS (Owner Number: 9020456)

Owner / Operator Contact Address

600 DEPOT ST., --, Latrobe, PA 15650, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cuvette Array (PN 246100) PN 82420 (SANI-SCOPE ASSEMBLY) UNR KIT SAMPLE TIPS - 6480/PKG (10309547, 078-K139-01) ACS SAMPLE CUP (10309545, PN 078-K137-01) SN 10445570 (PN 757347 STM1 Pipette Assembly) SN 10385209 (PN LMH15 Microsampling Insert) SN 10385209 (PN 502534 Molded Adapter Insert) ACS CUVETTE -32 CAVITY (10309546, PN 078-K138-01)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2025-09-08
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2025-12-31
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2025-08-19
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	1999-04-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-09-24
JRI	Cuvette, Thermostated	Clinical Chemistry	Class 1	862.2050	2025-08-19

Official Correspondent

Brian Kochanski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CARCLO TECHNICAL PLASTICS

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2530112	Carclo Technical Plastics - Export	Export, PA, US
3021917553	CARCLO TECHNICAL PLASTICS - Greensburg	Greensburg, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Similar Registrations

Registration Number	Establishment Name	Location
3042585783	NOVASCOPE BIOCHIPS INC.	Boston, MA, US
3009756327	Synergy Health Ede BV	Ede Gelderland, NL
3008850249	CHANGZHOU DSB MEDICAL CO., LTD	Changzhou City Jiangsu, CN
3014642322	PRECISION CONVERTING SOLUTIONS LTD.	Khlong Luang Pathum Thani, TH
8010096	OXOID, LTD.	BASINGSTOKE, HAMPSHIRE, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007135420. Last updated year: 2026. Please use registration number 3007135420 when referencing this establishment in official correspondence.