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FDA 510(k)

QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU

K-Number: K935475 · 1995-08-30

ApplicantSyntron Bioresearch, Inc.
Decision Date1995-08-30
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU is the device name listed in this FDA 510(k) record. The listed applicant is Syntron Bioresearch, Inc.. It received FDA 510(k) clearance on 1995-08-30 under 510(k) number K935475. 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 QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU?

QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU is a medical device that received FDA 510(k) clearance on 1995-08-30. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K935475.

When did QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU receive FDA 510(k) clearance?

QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU received FDA 510(k) clearance on 1995-08-30, under 510(k) number K935475.

Who is the listed applicant for QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU?

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

What is the FDA product code for QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU?

The FDA product code for QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU is GTZ.

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Other records listing Syntron Bioresearch, 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.

K993490QUICKSTRIP ONE STEP OPIATES TESTK993491QUICKPAC II ONE STEP OPIATES TESTK992990QUICKPAC II ONE STEP COCAINE TESTK992748DRUGCHECK X MULTIDRUG SCREENING DEVICEK992207QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEMK990325QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE

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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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