Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680687

FEI Number

3003285777

Entity Name

CHROMAGAR

City/State/Country

Saint-Denis Seine-Saint-Denis, FR

Establishment Address

29 Avenue George Sand, Saint-Denis Seine-Saint-Denis 93210, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CHROMAGAR (Owner Number: 9010665)

Owner / Operator Contact Address

29 Avenue George Sand, --, La Plaine Saint Denis, FR-93 93210, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CHROMagar TBX CHROMagar Staph Aureus CHROMagar Campylobacter CHROMagar STEC CHROMagar ESBL CHROMagar KPC CHROMagar Vibrio Rambach Agar CHROMagar O157 CHROMagar Y. enterocolitica CHROMagar C. Difficile CHROMagar Listeria Identification CHROMagar Staphylococcus CHROMagar B. cereus CHROMagar Acinetobacter CHROMagar Candida CHROMagar ECC CHROMagar StrepB CHROMagar Ecoli RambaCHROM KPC CHROMagar Salmonella CHROMagar CCA CHROMagar mSuperCARBA CHROMagar Pseudomonas CHROMagar Liquid ECC CHROMagar VRE CHROMagar Streptococcus CHROMagar Listeria CHROMagar Salmonella Plus CHROMagar Malassezia CHROMagar Mastitis CHROMagar E.sakazakii CHROMagar MRSA CHROMagar Orientation CHROMagar COL-APSE CHROMagar C. perfringens CHROMagar Enterobacteria CHROMagar Serratia CHROMagar StrepA CHROMagar Cronobacter CHROMagar LIN-R CHROMagar Candida Plus CHROMagar Pasteurella CHROMagar Mycoplasma CHROMagar B.cepacia CHROMagar Liquid ECC CHROMagar Orientation AquaCHROM ECC LIM RambaQUICK StrepB AquaCHROM Enterococcus RambaQUICK Salmonella

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	1995-11-28
JSC	Culture Media, General Nutrient Broth	Microbiology	Class 1	866.2350	1994-06-16
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	2006-05-09
JSD	Culture Media, Selective Broth	Microbiology	Class 1	866.2360	2009-04-01

Official Correspondent

ALBERTO LERNER

US Agent Details

Ina Hairston Business: DRG International Email: qa@drg-international.com Phone: (973) 5647555

Related Public Records

Same Entity

CHROMAGAR

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K862389	Otisville Biotech, Inc.	BIOTIS ACETAMIDE AGAR	1986-07-03
K811644	Hardy Media	HEKTOEN ENTERIC AGAR	1981-07-02
K832535	Otisville Biotech, Inc.	HEKTOEN ENTERIC AGAR PLATE	1983-10-04
K811331	Acumedia Manufacturers, Inc.	SF BROTH	1981-05-29
K872058	Orion Corp.	ORICULT-N CULTURE-PADDLE	1987-06-10

Similar Registrations

Registration Number	Establishment Name	Location
3005182159	HIMEDIA LABORATORIES PRIVATE LIMITED	NASHIK Maharashtra, IN
2016672	KEY SCIENTIFIC PRODUCTS	Stamford, TX, US
3033815621	GUANGDONG HUANKAI BIOLOGY SCI.&TECH.CO.,LTD	Zhaoqing Guangdong, CN
8023060	BIO-RAD	STEENVOORDE Nord, FR
9610649	MEDICAL WIRE AND EQUIPMENT CO. LTD.	CORSHAM, WILTSHIRE, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680687. Last updated year: 2026. Please use registration number 9680687 when referencing this establishment in official correspondence.