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FDA 510(k)

TARGET STREP A

K-Number: K880460 · 1988-03-03

ApplicantV-Tech, Inc.
Decision Date1988-03-03
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TARGET STREP A is the device name listed in this FDA 510(k) record. The listed applicant is V-Tech, Inc.. It received FDA 510(k) clearance on 1988-03-03 under 510(k) number K880460. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TARGET STREP A?

TARGET STREP A is a medical device that received FDA 510(k) clearance on 1988-03-03. The listed applicant is V-Tech, Inc.. The 510(k) number is K880460.

When did TARGET STREP A receive FDA 510(k) clearance?

TARGET STREP A received FDA 510(k) clearance on 1988-03-03, under 510(k) number K880460.

Who is the listed applicant for TARGET STREP A?

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

What is the FDA product code for TARGET STREP A?

The FDA product code for TARGET STREP A is GTZ.

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Other records listing V-Tech, 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.

K914303TARGET(TM)-HOGK910892TARGET(TM) CANNABINOIDS-V TESTK910893TARGET(TM) CANNABINOIDS-R TESTK910739TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)K910738TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)K910123TARGET COCAINE METABOLITE-V

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Related Devices (Code: GTZ)

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.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K011709UNI-GOLD STREP A TEST KITTrinity Biotech, PlcK010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962060STREP A OIA MAXBiostar, 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.

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