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FDA 510(k)

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN

K-Number: K850587 · 1985-03-14

ApplicantApplications Lab
Decision Date1985-03-14
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN is the device name listed in this FDA 510(k) record. The listed applicant is Applications Lab. It received FDA 510(k) clearance on 1985-03-14 under 510(k) number K850587. 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 SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN?

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN is a medical device that received FDA 510(k) clearance on 1985-03-14. The listed applicant is Applications Lab. The 510(k) number is K850587.

When did SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN receive FDA 510(k) clearance?

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN received FDA 510(k) clearance on 1985-03-14, under 510(k) number K850587.

Who is the listed applicant for SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN?

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

What is the FDA product code for SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN?

The FDA product code for SPQ TEST SYSTEM FOR ALPHA, - 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 Applications Lab 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.

K850586SPQ TEST SYSTEM FOR IMMUNOGLOBULIN MK850589SPQ TEST SYSTEM FOR TRANSFERRINK850584SPQ TEST SYSTEM FOR HAPTOGLOBINK850603SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULINK850588SPQ TEST SYSTEM FOR COMPLEMENT C3K850590SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

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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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