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FDA 510(k)

IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2

K-Number: K900072 · 1990-01-24

ApplicantGeneral Biometrics, Inc.
Decision Date1990-01-24
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 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 1990-01-24 under 510(k) number K900072. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2?

IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 is a medical device that received FDA 510(k) clearance on 1990-01-24. The listed applicant is General Biometrics, Inc.. The 510(k) number is K900072.

When did IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 receive FDA 510(k) clearance?

IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 received FDA 510(k) clearance on 1990-01-24, under 510(k) number K900072.

Who is the listed applicant for IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2?

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 AUTOIMMUNITY SCREENING PANEL 2?

The FDA product code for IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 is LJM.

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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: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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