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FDA 510(k)

EZ COMPLEMENT C1

K-Number: K891904 · 1989-04-14

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

Device Summary

EZ COMPLEMENT C1 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 K891904. The device is classified under product code DAC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ COMPLEMENT C1?

EZ COMPLEMENT C1 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 K891904.

When did EZ COMPLEMENT C1 receive FDA 510(k) clearance?

EZ COMPLEMENT C1 received FDA 510(k) clearance on 1989-04-14, under 510(k) number K891904.

Who is the listed applicant for EZ COMPLEMENT C1?

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 C1?

The FDA product code for EZ COMPLEMENT C1 is DAC.

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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

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Related Devices (Code: DAC)

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.

K771583FLUORESCENT ANTI. ANTI-HUMAN C3Burroughs Wellcome 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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