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FDA 510(k)

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

K-Number: K850586 · 1985-03-14

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

Device Summary

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M 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 K850586. The device is classified under product code DAO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M?

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M 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 K850586.

When did SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M receive FDA 510(k) clearance?

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M received FDA 510(k) clearance on 1985-03-14, under 510(k) number K850586.

Who is the listed applicant for SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M?

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 IMMUNOGLOBULIN M?

The FDA product code for SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M is DAO.

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.

K850587SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSINK850589SPQ 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: DAO)

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.

K040431ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2Roche Diagnostics Corp.K982639SPIFE URINE IFEHelena LaboratoriesK955908BOEHRINGER MANNHEIM IGM ASSAYBoehringer Mannheim Corp.K841992MODIFICATION TO ACS CORONARY GUIDINGAdvanced Cardiovascular Systems, Inc.K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDako Corp.K800450GEMENI IGM ASSAYElectro-Nucleonics Laboratories, Inc.

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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