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FDA 510(k)

HUMAN C4 COMPLEMENT CONTROL SERUM

K-Number: K772004 · 1977-11-03

ApplicantG.D. Searle and Co.
Decision Date1977-11-03
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN C4 COMPLEMENT CONTROL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is G.D. Searle and Co.. It received FDA 510(k) clearance on 1977-11-03 under 510(k) number K772004. 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 HUMAN C4 COMPLEMENT CONTROL SERUM?

HUMAN C4 COMPLEMENT CONTROL SERUM is a medical device that received FDA 510(k) clearance on 1977-11-03. The listed applicant is G.D. Searle and Co.. The 510(k) number is K772004.

When did HUMAN C4 COMPLEMENT CONTROL SERUM receive FDA 510(k) clearance?

HUMAN C4 COMPLEMENT CONTROL SERUM received FDA 510(k) clearance on 1977-11-03, under 510(k) number K772004.

Who is the listed applicant for HUMAN C4 COMPLEMENT CONTROL SERUM?

The FDA 510(k) record lists G.D. Searle and Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMAN C4 COMPLEMENT CONTROL SERUM?

The FDA product code for HUMAN C4 COMPLEMENT CONTROL SERUM is DBI.

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Other records listing G.D. Searle and Co. 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.

K821159IN-LINE OXYGEN MONITORING SYSTEMK811068BYPASS COILK811071VENOUS OXYGEN PROBEK803238INTRAVASCULAR CATHETERK810630SILICONE ELASTOMER COATED LATEX FOLEYK810131ADMINISTRATION SET

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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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