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FDA 510(k)

DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM

K-Number: K993294 · 1999-10-25

ApplicantDiamedix Corp.
Decision Date1999-10-25
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1999-10-25 under 510(k) number K993294. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM?

DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1999-10-25. The listed applicant is Diamedix Corp.. The 510(k) number is K993294.

When did DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM receive FDA 510(k) clearance?

DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM received FDA 510(k) clearance on 1999-10-25, under 510(k) number K993294.

Who is the listed applicant for DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM?

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 DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM?

The FDA product code for DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM is LKJ.

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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: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, Inc.

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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