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FDA 510(k)

GOAT ANTI-HUMAN COMPLEMENT C4

K-Number: K802196 · 1980-10-31

ApplicantProtos Laboratories
Decision Date1980-10-31
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GOAT ANTI-HUMAN COMPLEMENT C4 is the device name listed in this FDA 510(k) record. The listed applicant is Protos Laboratories. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802196. 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 GOAT ANTI-HUMAN COMPLEMENT C4?

GOAT ANTI-HUMAN COMPLEMENT C4 is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Protos Laboratories. The 510(k) number is K802196.

When did GOAT ANTI-HUMAN COMPLEMENT C4 receive FDA 510(k) clearance?

GOAT ANTI-HUMAN COMPLEMENT C4 received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802196.

Who is the listed applicant for GOAT ANTI-HUMAN COMPLEMENT C4?

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

What is the FDA product code for GOAT ANTI-HUMAN COMPLEMENT C4?

The FDA product code for GOAT ANTI-HUMAN COMPLEMENT C4 is DBI.

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.

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Other records listing Protos Laboratories 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.

K802177GOAT ANTI-HUMAN IGMK802257GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFICK791560GOAT ANTI-HUMAN C-REACTIVE PROTEINK791605GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSINK791115GOAR ANTI-HUMAN LAMBODA CHAIN

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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