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FDA 510(k)

OSOM ULTRA STREP A TEST, MODEL 147

K-Number: K992658 · 2000-01-18

ApplicantWyntek Diagnostics, Inc.
Decision Date2000-01-18
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OSOM ULTRA STREP A TEST, MODEL 147 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 2000-01-18 under 510(k) number K992658. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSOM ULTRA STREP A TEST, MODEL 147?

OSOM ULTRA STREP A TEST, MODEL 147 is a medical device that received FDA 510(k) clearance on 2000-01-18. The listed applicant is Wyntek Diagnostics, Inc.. The 510(k) number is K992658.

When did OSOM ULTRA STREP A TEST, MODEL 147 receive FDA 510(k) clearance?

OSOM ULTRA STREP A TEST, MODEL 147 received FDA 510(k) clearance on 2000-01-18, under 510(k) number K992658.

Who is the listed applicant for OSOM ULTRA STREP A TEST, MODEL 147?

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 ULTRA STREP A TEST, MODEL 147?

The FDA product code for OSOM ULTRA STREP A TEST, MODEL 147 is GTY.

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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.

K990578OSOM CARD II HCG-URINE TEST, MODEL 102K990576OSOM CARD PREGNANCY TEST, MODEL 103K974159OSOM HCG-URINE TEST MODEL 101K973879OSOM CARD HCG-URINE TESTK972231OSOM MONO TEST 143K965184PERFECTA PREGNANCY TEST

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Related Devices (Code: GTY)

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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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