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FDA 510(k)

TINA-QUANT ALPHA-1 ANTITRYPSIN

K-Number: K010978 · 2001-05-18

ApplicantRochdiag
Decision Date2001-05-18
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT ALPHA-1 ANTITRYPSIN is the device name listed in this FDA 510(k) record. The listed applicant is Rochdiag. It received FDA 510(k) clearance on 2001-05-18 under 510(k) number K010978. The device is classified under product code DEM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINA-QUANT ALPHA-1 ANTITRYPSIN?

TINA-QUANT ALPHA-1 ANTITRYPSIN is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Rochdiag. The 510(k) number is K010978.

When did TINA-QUANT ALPHA-1 ANTITRYPSIN receive FDA 510(k) clearance?

TINA-QUANT ALPHA-1 ANTITRYPSIN received FDA 510(k) clearance on 2001-05-18, under 510(k) number K010978.

Who is the listed applicant for TINA-QUANT ALPHA-1 ANTITRYPSIN?

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

What is the FDA product code for TINA-QUANT ALPHA-1 ANTITRYPSIN?

The FDA product code for TINA-QUANT ALPHA-1 ANTITRYPSIN is DEM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Rochdiag 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.

K063744COBAS INTEGRA C 111K011658CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS

Related Devices (Code: DEM)

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.

K123256HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUSThe Binding Site Group , Ltd.K063610DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.K053072N ANTISERA TO HUMAN ALPHA1-ANTITRYPSINDade Behring, Inc.K052819VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K050596QUANTIA A1-ATBiokit, S.A.K031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYBayer Diagnostics Corp.

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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