FDA 510(k)

BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2

K-Number: K902661 · 1990-07-31

Decision Date1990-07-31

Product CodeGQL

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-07-31 under 510(k) number K902661. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2?

BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 is a medical device that received FDA 510(k) clearance on 1990-07-31. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K902661.

When did BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 receive FDA 510(k) clearance?

BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 received FDA 510(k) clearance on 1990-07-31, under 510(k) number K902661.

Who is the listed applicant for BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2?

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

What is the FDA product code for BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2?

The FDA product code for BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 is GQL.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: GQL)

K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KITMillipore Corporation K984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated Diagnostics, Inc.

Official Source

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