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FDA 510(k)

GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX

K-Number: K941459 · 1995-02-03

ApplicantBaxter Diagnostics, Inc.
Decision Date1995-02-03
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX 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 1995-02-03 under 510(k) number K941459. 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 GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX?

GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX is a medical device that received FDA 510(k) clearance on 1995-02-03. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K941459.

When did GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX receive FDA 510(k) clearance?

GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX received FDA 510(k) clearance on 1995-02-03, under 510(k) number K941459.

Who is the listed applicant for GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX?

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 GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX?

The FDA product code for GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX is JWY.

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Other records listing Baxter Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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