Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM

K-Number: K890561 · 1989-02-23

ApplicantAtlantic Antibodies
Decision Date1989-02-23
Product CodeCFQ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Antibodies. It received FDA 510(k) clearance on 1989-02-23 under 510(k) number K890561. The device is classified under product code CFQ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPQ(TM) ANTIBODY REAGENT SET II FOR IGM?

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM is a medical device that received FDA 510(k) clearance on 1989-02-23. The listed applicant is Atlantic Antibodies. The 510(k) number is K890561.

When did SPQ(TM) ANTIBODY REAGENT SET II FOR IGM receive FDA 510(k) clearance?

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM received FDA 510(k) clearance on 1989-02-23, under 510(k) number K890561.

Who is the listed applicant for SPQ(TM) ANTIBODY REAGENT SET II FOR IGM?

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

What is the FDA product code for SPQ(TM) ANTIBODY REAGENT SET II FOR IGM?

The FDA product code for SPQ(TM) ANTIBODY REAGENT SET II FOR IGM is CFQ.

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 Atlantic Antibodies 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.

K892526SPQ TM TEST SYSTEM II FOR CRPK891154SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO BK890563SPQ(TM) ANTIBODY REAGENT SET II FOR TRFK890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPTK890416SPQ(TM) ANTIBODY REAGENT SET II FOR IGGK890417SPQ(TM) ANTIBODY REAGENT SET II FOR C3

View all 18 devices →

Related Devices (Code: CFQ)

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.

K981786IGA MININEPH ANTISERUMThe Binding Site, Ltd.K990551IGG FLEX REAGENT CARTRIDGEDade Behring, Inc.K990552IMMUNOGLOBULIN A TEST SYSTEMDade Behring, Inc.K990553IGM FLEX REAGENT CARTRIDGEDade Behring, Inc.K951013OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K951055OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENTOlympus America, 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.

↑