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FDA 510(k)

EZ COMPLEMENT C4

K-Number: K892129 · 1989-04-14

ApplicantDiamedix Corp.
Decision Date1989-04-14
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EZ COMPLEMENT C4 is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1989-04-14 under 510(k) number K892129. 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 EZ COMPLEMENT C4?

EZ COMPLEMENT C4 is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Diamedix Corp.. The 510(k) number is K892129.

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

EZ COMPLEMENT C4 received FDA 510(k) clearance on 1989-04-14, under 510(k) number K892129.

Who is the listed applicant for EZ COMPLEMENT C4?

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

What is the FDA product code for EZ COMPLEMENT C4?

The FDA product code for EZ COMPLEMENT C4 is DBI.

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Other records listing Diamedix Corp. 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.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

View all 68 devices →

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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