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FDA 510(k)

IMMUNOWELL TPO (MICROSOME) TEST

K-Number: K905486 · 1991-01-03

ApplicantGeneral Biometrics, Inc.
Decision Date1991-01-03
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOWELL TPO (MICROSOME) 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 1991-01-03 under 510(k) number K905486. The device is classified under product code JNL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOWELL TPO (MICROSOME) TEST?

IMMUNOWELL TPO (MICROSOME) TEST is a medical device that received FDA 510(k) clearance on 1991-01-03. The listed applicant is General Biometrics, Inc.. The 510(k) number is K905486.

When did IMMUNOWELL TPO (MICROSOME) TEST receive FDA 510(k) clearance?

IMMUNOWELL TPO (MICROSOME) TEST received FDA 510(k) clearance on 1991-01-03, under 510(k) number K905486.

Who is the listed applicant for IMMUNOWELL TPO (MICROSOME) 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 IMMUNOWELL TPO (MICROSOME) TEST?

The FDA product code for IMMUNOWELL TPO (MICROSOME) TEST is JNL.

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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: JNL)

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.

K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc.K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K112933ACCESS THYROGLOBULIN ANITBODYBeckman Coulter, Inc.K072661IMMUNOCAP THYRLOBULIN IMMUNOCAPPhadia US, Inc.K062516ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)Beckman Coulter, Inc.K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAMonobind

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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