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FDA 510(k)

OSOM STREP A TEST

K-Number: K961423 · 1996-10-11

ApplicantWyntek Diagnostics, Inc.
Decision Date1996-10-11
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OSOM STREP A TEST is the device name listed in this FDA 510(k) record. The listed applicant is Wyntek Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-10-11 under 510(k) number K961423. 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 OSOM STREP A TEST?

OSOM STREP A TEST is a medical device that received FDA 510(k) clearance on 1996-10-11. The listed applicant is Wyntek Diagnostics, Inc.. The 510(k) number is K961423.

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

OSOM STREP A TEST received FDA 510(k) clearance on 1996-10-11, under 510(k) number K961423.

Who is the listed applicant for OSOM STREP A TEST?

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

What is the FDA product code for OSOM STREP A TEST?

The FDA product code for OSOM STREP A TEST is GTZ.

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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.

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Other records listing Wyntek Diagnostics, 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.

K992658OSOM ULTRA STREP A TEST, MODEL 147K990576OSOM CARD PREGNANCY TEST, MODEL 103K990578OSOM CARD II HCG-URINE TEST, MODEL 102K974159OSOM HCG-URINE TEST MODEL 101K973879OSOM CARD HCG-URINE TESTK972231OSOM MONO TEST 143

View all 12 devices →

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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