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FDA 510(k)

SPQ(TM) ANTIBODY REAGENT SET II FOR C4

K-Number: K890564 · 1989-02-17

ApplicantAtlantic Antibodies
Decision Date1989-02-17
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ(TM) ANTIBODY REAGENT SET II FOR C4 is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Antibodies. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K890564. The device is classified under product code DBI. 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 C4?

SPQ(TM) ANTIBODY REAGENT SET II FOR C4 is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Atlantic Antibodies. The 510(k) number is K890564.

When did SPQ(TM) ANTIBODY REAGENT SET II FOR C4 receive FDA 510(k) clearance?

SPQ(TM) ANTIBODY REAGENT SET II FOR C4 received FDA 510(k) clearance on 1989-02-17, under 510(k) number K890564.

Who is the listed applicant for SPQ(TM) ANTIBODY REAGENT SET II FOR C4?

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 C4?

The FDA product code for SPQ(TM) ANTIBODY REAGENT SET II FOR C4 is DBI.

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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 TRFK890561SPQ(TM) ANTIBODY REAGENT SET II FOR IGMK890416SPQ(TM) ANTIBODY REAGENT SET II FOR IGGK890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPT

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Related Devices (Code: DBI)

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.

K100455SPAPLUS ANALYZERThe Binding SiteK012359TINA-QUANT COMPLEMENT C4 TEST SYSTEMRoche Diagnostics Corp.K010325WAKO AUTOKIT C4Wako Chemicals USA, Inc.K000468RANDOX COMPLEMENT C4Randox Laboratories, Ltd.K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.K981785C4 MININEPH ANTISERUMThe Binding Site, Ltd.

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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