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FDA 510(k)

DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM

K-Number: K980759 · 1998-04-23

ApplicantDiamedix Corp.
Decision Date1998-04-23
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIAMEDIX IS-ENA-6 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 1998-04-23 under 510(k) number K980759. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM?

DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-23. The listed applicant is Diamedix Corp.. The 510(k) number is K980759.

When did DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM receive FDA 510(k) clearance?

DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM received FDA 510(k) clearance on 1998-04-23, under 510(k) number K980759.

Who is the listed applicant for DIAMEDIX IS-ENA-6 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-ENA-6 SCREEN TEST SYSTEM?

The FDA product code for DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM is LLL.

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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: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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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