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FDA 510(k)

IS-ANTI-SM TEST SYSTEM

K-Number: K970220 · 1997-04-08

ApplicantDiamedix Corp.
Decision Date1997-04-08
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IS-ANTI-SM 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 1997-04-08 under 510(k) number K970220. 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 IS-ANTI-SM TEST SYSTEM?

IS-ANTI-SM TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-08. The listed applicant is Diamedix Corp.. The 510(k) number is K970220.

When did IS-ANTI-SM TEST SYSTEM receive FDA 510(k) clearance?

IS-ANTI-SM TEST SYSTEM received FDA 510(k) clearance on 1997-04-08, under 510(k) number K970220.

Who is the listed applicant for IS-ANTI-SM 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 IS-ANTI-SM TEST SYSTEM?

The FDA product code for IS-ANTI-SM 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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