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FDA 510(k)

IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST

K-Number: K894975 · 1989-09-13

ApplicantGeneral Biometrics, Inc.
Decision Date1989-09-13
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST is the device name listed in this FDA 510(k) record. The listed applicant is General Biometrics, Inc.. It received FDA 510(k) clearance on 1989-09-13 under 510(k) number K894975. 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 IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST?

IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST is a medical device that received FDA 510(k) clearance on 1989-09-13. The listed applicant is General Biometrics, Inc.. The 510(k) number is K894975.

When did IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST receive FDA 510(k) clearance?

IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST received FDA 510(k) clearance on 1989-09-13, under 510(k) number K894975.

Who is the listed applicant for IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST?

The FDA 510(k) record lists General Biometrics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST?

The FDA product code for IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST is KTN.

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Other records listing General Biometrics, 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.

K924843IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANELK920400IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TESTK920401IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TESTK911627IMMUNODOT BORRELIA (LYME) TESTK911599IMMUNOWELL LYME (P39 RECOMBINANT) TESTK911590IMMUNOWELL BORRELIA (LYME)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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