FDA 510(k)

ENRICHED CULTURE MEDIUM

K-Number: K850735 · 1985-03-16

ApplicantRoseville Medical Laboratoriesu

Decision Date1985-03-16

Product CodeKZI

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ENRICHED CULTURE MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Roseville Medical Laboratoriesu. It received FDA 510(k) clearance on 1985-03-16 under 510(k) number K850735. The device is classified under product code KZI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENRICHED CULTURE MEDIUM?

ENRICHED CULTURE MEDIUM is a medical device that received FDA 510(k) clearance on 1985-03-16. The listed applicant is Roseville Medical Laboratoriesu. The 510(k) number is K850735.

When did ENRICHED CULTURE MEDIUM receive FDA 510(k) clearance?

ENRICHED CULTURE MEDIUM received FDA 510(k) clearance on 1985-03-16, under 510(k) number K850735.

Who is the listed applicant for ENRICHED CULTURE MEDIUM?

The FDA 510(k) record lists Roseville Medical Laboratoriesu as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENRICHED CULTURE MEDIUM?

The FDA product code for ENRICHED CULTURE MEDIUM is KZI.

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Other records listing Roseville Medical Laboratoriesu as applicant

K850733MULTIPURPOSE CULTURE MEDIUM K850736SELECTIVE CULTURE MEDIUM K850734DIFFERENTIAL CULTURE MEDIUM K850737TRANSPORT CULTURE MEDIUM K850738SUPPLEMENT FOR CULTURE MEDIUM K850732CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI

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Related Devices (Code: KZI)

K884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)Oxoid U.S.A., Inc.K881995DIAMOND'S MEDIUM MODIFIEDRemel Co.K880122MIDDLEBROOK 7H9 BROTHHardy Media K880131LOWENSTEIN-JENSEN, GRUFTHardy Media K880134MIDDLEBROOK 7H11 AGARHardy Media K880138WALLENSTEIN MEDIUM SLANTHardy Media

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.