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FDA 510(k)

ACCUTEX IM RBC TEST

K-Number: K924037 · 1992-11-02

ApplicantJ.S. Medical Assoc.
Decision Date1992-11-02
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACCUTEX IM RBC TEST is the device name listed in this FDA 510(k) record. The listed applicant is J.S. Medical Assoc.. It received FDA 510(k) clearance on 1992-11-02 under 510(k) number K924037. 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 ACCUTEX IM RBC TEST?

ACCUTEX IM RBC TEST is a medical device that received FDA 510(k) clearance on 1992-11-02. The listed applicant is J.S. Medical Assoc.. The 510(k) number is K924037.

When did ACCUTEX IM RBC TEST receive FDA 510(k) clearance?

ACCUTEX IM RBC TEST received FDA 510(k) clearance on 1992-11-02, under 510(k) number K924037.

Who is the listed applicant for ACCUTEX IM RBC TEST?

The FDA 510(k) record lists J.S. Medical Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUTEX IM RBC TEST?

The FDA product code for ACCUTEX IM RBC TEST is KTN.

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Other records listing J.S. Medical Assoc. 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.

K932752VISI-SPOTK932688EYE SPOT IM TESTK932180EYE SPOT CRP TESTK932551ACCUTEX IM LATEX TESTK926112ACCUTEX BETA-HCG TESTK924332ACCUTEX CRP LATEX 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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