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FDA 510(k)

FIAX COMPLEMENT C4 TEST KIT

K-Number: K830669 · 1983-04-08

ApplicantIntl. Diagnostic Technology
Decision Date1983-04-08
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIAX COMPLEMENT C4 TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1983-04-08 under 510(k) number K830669. 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 FIAX COMPLEMENT C4 TEST KIT?

FIAX COMPLEMENT C4 TEST KIT is a medical device that received FDA 510(k) clearance on 1983-04-08. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K830669.

When did FIAX COMPLEMENT C4 TEST KIT receive FDA 510(k) clearance?

FIAX COMPLEMENT C4 TEST KIT received FDA 510(k) clearance on 1983-04-08, under 510(k) number K830669.

Who is the listed applicant for FIAX COMPLEMENT C4 TEST KIT?

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

What is the FDA product code for FIAX COMPLEMENT C4 TEST KIT?

The FDA product code for FIAX COMPLEMENT C4 TEST KIT is DBI.

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Other records listing Intl. Diagnostic Technology 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.

K850591FIAX TOXO-M ANTIBODIES TEST KITK843570FIAX HAPTOGLOBIN TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN TEST KIT

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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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