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FDA 510(k)

AUTOSTAT II ANTI-TPO

K-Number: K943580 · 1995-04-17

ApplicantCogent Diagnotics , Ltd.
Decision Date1995-04-17
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT II ANTI-TPO is the device name listed in this FDA 510(k) record. The listed applicant is Cogent Diagnotics , Ltd.. It received FDA 510(k) clearance on 1995-04-17 under 510(k) number K943580. 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 AUTOSTAT II ANTI-TPO?

AUTOSTAT II ANTI-TPO is a medical device that received FDA 510(k) clearance on 1995-04-17. The listed applicant is Cogent Diagnotics , Ltd.. The 510(k) number is K943580.

When did AUTOSTAT II ANTI-TPO receive FDA 510(k) clearance?

AUTOSTAT II ANTI-TPO received FDA 510(k) clearance on 1995-04-17, under 510(k) number K943580.

Who is the listed applicant for AUTOSTAT II ANTI-TPO?

The FDA 510(k) record lists Cogent Diagnotics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOSTAT II ANTI-TPO?

The FDA product code for AUTOSTAT II ANTI-TPO is JNL.

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Other records listing Cogent Diagnotics , Ltd. 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.

K003054AUTOSTAT II ENA-6 PROFILE ELISAK003057AUTOSTAT II ENA-4 PROFILE ELISAK002215AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISAK993557AUTOSTAT II RHEUMATOID FACTOR IGA ELISAK994338AUTOSTAT II RHEUMATOID FACTOR IGM ELISAK993085AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA

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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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