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FDA 510(k)

OSOM MONO TEST 143

K-Number: K972231 · 1997-08-26

ApplicantWyntek Diagnostics, Inc.
Decision Date1997-08-26
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OSOM MONO TEST 143 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 1997-08-26 under 510(k) number K972231. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSOM MONO TEST 143?

OSOM MONO TEST 143 is a medical device that received FDA 510(k) clearance on 1997-08-26. The listed applicant is Wyntek Diagnostics, Inc.. The 510(k) number is K972231.

When did OSOM MONO TEST 143 receive FDA 510(k) clearance?

OSOM MONO TEST 143 received FDA 510(k) clearance on 1997-08-26, under 510(k) number K972231.

Who is the listed applicant for OSOM MONO TEST 143?

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 MONO TEST 143?

The FDA product code for OSOM MONO TEST 143 is KTN.

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 147K990578OSOM CARD II HCG-URINE TEST, MODEL 102K990576OSOM CARD PREGNANCY TEST, MODEL 103K974159OSOM HCG-URINE TEST MODEL 101K973879OSOM CARD HCG-URINE TESTK965184PERFECTA PREGNANCY TEST

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Related Devices (Code: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

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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