J. Knipper and Company, Inc.

FDA Device Registration & Listing · Charlestown, IN, US · Registration 3014680791

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014680791
FEI Number
3014680791
Entity Name
J. Knipper and Company, Inc.
City/State/Country
Charlestown, IN, US
Establishment Address
1250 Patrol Road, Charlestown, IN 47111, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
J. KNIPPER AND COMPANY, INC. (Owner Number: 9053305)
Owner / Operator Contact Address
ONE HEALTHCARE WAY, --, Lakewood, NJ 08701, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K161553
PMA Number
N/A

All Registered Proprietary Names

Becton, Dickinson and Company

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2024-07-11
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2018-07-02

Official Correspondent

Dominique Bourdeau-Oscar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

J. KNIPPER AND COMPANY, 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
2246553 J. KNIPPER AND COMPANY, INC. LAKEWOOD, NJ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23
K143687 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material 2015-07-17
K143376 Siemens Healthcare Diagnostics, Inc. ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material 2014-12-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014680791. Last updated year: 2026. Please use registration number 3014680791 when referencing this establishment in official correspondence.
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