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FDA 510(k)

CYSTINE TRYPTIC AGAR W/DEXTROSE

K-Number: K844542 · 1985-01-16

ApplicantbioMerieux, Inc.
Decision Date1985-01-16
Product CodeJSF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYSTINE TRYPTIC AGAR W/DEXTROSE is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 1985-01-16 under 510(k) number K844542. The device is classified under product code JSF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYSTINE TRYPTIC AGAR W/DEXTROSE?

CYSTINE TRYPTIC AGAR W/DEXTROSE is a medical device that received FDA 510(k) clearance on 1985-01-16. The listed applicant is bioMerieux, Inc.. The 510(k) number is K844542.

When did CYSTINE TRYPTIC AGAR W/DEXTROSE receive FDA 510(k) clearance?

CYSTINE TRYPTIC AGAR W/DEXTROSE received FDA 510(k) clearance on 1985-01-16, under 510(k) number K844542.

Who is the listed applicant for CYSTINE TRYPTIC AGAR W/DEXTROSE?

The FDA 510(k) record lists bioMerieux, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYSTINE TRYPTIC AGAR W/DEXTROSE?

The FDA product code for CYSTINE TRYPTIC AGAR W/DEXTROSE is JSF.

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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.

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