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FDA 510(k)

GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN

K-Number: K791605 · 1979-09-04

ApplicantProtos Laboratories
Decision Date1979-09-04
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN is the device name listed in this FDA 510(k) record. The listed applicant is Protos Laboratories. It received FDA 510(k) clearance on 1979-09-04 under 510(k) number K791605. 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 GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN?

GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Protos Laboratories. The 510(k) number is K791605.

When did GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN receive FDA 510(k) clearance?

GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791605.

Who is the listed applicant for GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN?

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

What is the FDA product code for GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN?

The FDA product code for GOAT ANTI-HUMAN 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.

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Other records listing Protos Laboratories 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.

K802177GOAT ANTI-HUMAN IGMK802196GOAT ANTI-HUMAN COMPLEMENT C4K802257GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFICK791560GOAT ANTI-HUMAN C-REACTIVE PROTEINK791115GOAR ANTI-HUMAN LAMBODA CHAIN

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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