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FDA 510(k)

TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY

K-Number: K972640 · 1998-01-09

ApplicantBoehringer Mannheim Corp.
Decision Date1998-01-09
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1998-01-09 under 510(k) number K972640. 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 PARTICLE-1-ANTITRYPSIN ASSAY?

TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY is a medical device that received FDA 510(k) clearance on 1998-01-09. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K972640.

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

TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY received FDA 510(k) clearance on 1998-01-09, under 510(k) number K972640.

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

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

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

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

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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