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FDA 510(k)

ANTI-SCI-70 MICROASSAY

K-Number: K902915 · 1990-09-06

ApplicantDiamedix Corp.
Decision Date1990-09-06
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-SCI-70 MICROASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1990-09-06 under 510(k) number K902915. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-SCI-70 MICROASSAY?

ANTI-SCI-70 MICROASSAY is a medical device that received FDA 510(k) clearance on 1990-09-06. The listed applicant is Diamedix Corp.. The 510(k) number is K902915.

When did ANTI-SCI-70 MICROASSAY receive FDA 510(k) clearance?

ANTI-SCI-70 MICROASSAY received FDA 510(k) clearance on 1990-09-06, under 510(k) number K902915.

Who is the listed applicant for ANTI-SCI-70 MICROASSAY?

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 ANTI-SCI-70 MICROASSAY?

The FDA product code for ANTI-SCI-70 MICROASSAY is LJM.

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Other records listing Diamedix Corp. as applicant

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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: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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