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FDA 510(k)

IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4

K-Number: K903047 · 1990-08-09

ApplicantGeneral Biometrics, Inc.
Decision Date1990-08-09
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 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 1990-08-09 under 510(k) number K903047. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4?

IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is General Biometrics, Inc.. The 510(k) number is K903047.

When did IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 receive FDA 510(k) clearance?

IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 received FDA 510(k) clearance on 1990-08-09, under 510(k) number K903047.

Who is the listed applicant for IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4?

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 IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4?

The FDA product code for IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 is LLL.

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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: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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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