FDA 510(k)

HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2

K-Number: K870814 · 1987-06-04

ApplicantMicroscan Div. Baxter Healthcare Corp.

Decision Date1987-06-04

Product CodeGQL

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 is the device name listed in this FDA 510(k) record. The listed applicant is Microscan Div. Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1987-06-04 under 510(k) number K870814. 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 HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2?

HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 is a medical device that received FDA 510(k) clearance on 1987-06-04. The listed applicant is Microscan Div. Baxter Healthcare Corp.. The 510(k) number is K870814.

When did HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 receive FDA 510(k) clearance?

HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 received FDA 510(k) clearance on 1987-06-04, under 510(k) number K870814.

Who is the listed applicant for HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2?

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

What is the FDA product code for HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2?

The FDA product code for HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 is GQL.

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Other records listing Microscan Div. Baxter Healthcare Corp. as applicant

K871232ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 K871229ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL K871233ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A K871228ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 K871231ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B K871234ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1

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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 K984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated Diagnostics, Inc.

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.