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FDA 510(k)

IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)

K-Number: K964766 · 1997-04-25

ApplicantBeckman Instruments, Inc.
Decision Date1997-04-25
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1997-04-25 under 510(k) number K964766. 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 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)?

IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) is a medical device that received FDA 510(k) clearance on 1997-04-25. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K964766.

When did IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) receive FDA 510(k) clearance?

IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) received FDA 510(k) clearance on 1997-04-25, under 510(k) number K964766.

Who is the listed applicant for IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)?

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

What is the FDA product code for IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)?

The FDA product code for IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) is DEM.

Related Clinical Trials

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

View all 281 devices →

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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