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FDA 510(k)

RANDOX COMPLEMENT C4

K-Number: K000468 · 2000-03-27

ApplicantRandox Laboratories, Ltd.
Decision Date2000-03-27
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RANDOX COMPLEMENT C4 is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2000-03-27 under 510(k) number K000468. 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 RANDOX COMPLEMENT C4?

RANDOX COMPLEMENT C4 is a medical device that received FDA 510(k) clearance on 2000-03-27. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K000468.

When did RANDOX COMPLEMENT C4 receive FDA 510(k) clearance?

RANDOX COMPLEMENT C4 received FDA 510(k) clearance on 2000-03-27, under 510(k) number K000468.

Who is the listed applicant for RANDOX COMPLEMENT C4?

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

What is the FDA product code for RANDOX COMPLEMENT C4?

The FDA product code for RANDOX COMPLEMENT C4 is DBI.

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Other records listing Randox Laboratories, Ltd. as applicant

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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.K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.K981785C4 MININEPH ANTISERUMThe Binding Site, Ltd.K993481K-ASSAY C4Kamiya Biomedical Co.

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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