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FDA 510(k)

DRIED GRAM NEGATIVE/CEFMETAZOLE

K-Number: K941317 · 1995-01-31

ApplicantBaxter Diagnostics, Inc.
Decision Date1995-01-31
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DRIED GRAM NEGATIVE/CEFMETAZOLE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-01-31 under 510(k) number K941317. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRIED GRAM NEGATIVE/CEFMETAZOLE?

DRIED GRAM NEGATIVE/CEFMETAZOLE is a medical device that received FDA 510(k) clearance on 1995-01-31. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K941317.

When did DRIED GRAM NEGATIVE/CEFMETAZOLE receive FDA 510(k) clearance?

DRIED GRAM NEGATIVE/CEFMETAZOLE received FDA 510(k) clearance on 1995-01-31, under 510(k) number K941317.

Who is the listed applicant for DRIED GRAM NEGATIVE/CEFMETAZOLE?

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

What is the FDA product code for DRIED GRAM NEGATIVE/CEFMETAZOLE?

The FDA product code for DRIED GRAM NEGATIVE/CEFMETAZOLE is JWY.

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Other records listing Baxter Diagnostics, Inc. as applicant

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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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