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FDA 510(k)

BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST

K-Number: K925183 · 1993-02-23

ApplicantPrinceton Biomedix
Decision Date1993-02-23
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Biomedix. It received FDA 510(k) clearance on 1993-02-23 under 510(k) number K925183. 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 BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST?

BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1993-02-23. The listed applicant is Princeton Biomedix. The 510(k) number is K925183.

When did BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST receive FDA 510(k) clearance?

BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST received FDA 510(k) clearance on 1993-02-23, under 510(k) number K925183.

Who is the listed applicant for BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST?

The FDA 510(k) record lists Princeton Biomedix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST?

The FDA product code for BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST is KTN.

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Other records listing Princeton Biomedix 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.

K942052LIFESIGN MI MYOGLOBINK925355BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TESTK930185OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEPK926308LIFESIGN HCG - ONE STEP HOME PREGNANCY TESTK901011BIOSIGN HCG-ONE STEP PREGNANCY TESTK894705BIOSPOT HCG-RAPID 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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