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FDA 510(k)

J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO

K-Number: K801669 · 1980-09-16

ApplicantJ.T. Baker Chemical Co.
Decision Date1980-09-16
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801669. 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 J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO?

J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K801669.

When did J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO receive FDA 510(k) clearance?

J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801669.

Who is the listed applicant for J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO?

The FDA product code for J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO is DEM.

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Other records listing J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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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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