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FDA 510(k)

OSOM HCG COMBO TEST

K-Number: K955141 · 1995-12-06

ApplicantWyntek Diagnostics, Inc.
Decision Date1995-12-06
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OSOM HCG COMBO 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 1995-12-06 under 510(k) number K955141. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSOM HCG COMBO TEST?

OSOM HCG COMBO TEST is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Wyntek Diagnostics, Inc.. The 510(k) number is K955141.

When did OSOM HCG COMBO TEST receive FDA 510(k) clearance?

OSOM HCG COMBO TEST received FDA 510(k) clearance on 1995-12-06, under 510(k) number K955141.

Who is the listed applicant for OSOM HCG COMBO 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 HCG COMBO TEST?

The FDA product code for OSOM HCG COMBO TEST is JJX.

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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

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Related Devices (Code: JJX)

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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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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