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FDA 510(k)

BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB

K-Number: K961024 · 1997-02-04

ApplicantPrinceton BioMeditech Corp.
Decision Date1997-02-04
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K961024. 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 MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB?

BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K961024.

When did BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB receive FDA 510(k) clearance?

BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB received FDA 510(k) clearance on 1997-02-04, under 510(k) number K961024.

Who is the listed applicant for BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB?

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

What is the FDA product code for BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB?

The FDA product code for BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB is KTN.

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Other records listing Princeton BioMeditech Corp. as applicant

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K251538Status™ COVID-19/Flu A&BK182157BioSign Flu A+BK133474BIOSIGN FLU A + B, STATUS FLU A & BK132465BIOSIGN FLU A + B, STATUS FLU A & BK083746BIOSIGN FLU A+BK100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD 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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