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FDA 510(k)

MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST

K-Number: K880157 · 1988-02-04

ApplicantSyva Co.
Decision Date1988-02-04
Product CodeGON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1988-02-04 under 510(k) number K880157. The device is classified under product code GON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST?

MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST is a medical device that received FDA 510(k) clearance on 1988-02-04. The listed applicant is Syva Co.. The 510(k) number is K880157.

When did MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST receive FDA 510(k) clearance?

MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST received FDA 510(k) clearance on 1988-02-04, under 510(k) number K880157.

Who is the listed applicant for MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST?

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

What is the FDA product code for MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST?

The FDA product code for MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST is GON.

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Other records listing Syva Co. as applicant

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Related Devices (Code: GON)

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.

K894262RUBELLA ANTIGEN AND CONTROL ANTIGENMicrobix Biosystems, Inc.K802939HERPES SIMPLEX TYPE IOrion Diagnostica, Inc.K802937RUBELLA VIRUS ANTIGENS & CONTROLSOrion Diagnostica, Inc.K780996RUBELISA TEST KITMicrobiological Assoc.

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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