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FDA 510(k)

3M ANTI-CARDIOLIPIN FAST(TM) TEST

K-Number: K913054 · 1991-11-27

Applicant3M Diagnostic Systems, Inc.
Decision Date1991-11-27
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

3M ANTI-CARDIOLIPIN FAST(TM) TEST is the device name listed in this FDA 510(k) record. The listed applicant is 3M Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-11-27 under 510(k) number K913054. The device is classified under product code MID. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M ANTI-CARDIOLIPIN FAST(TM) TEST?

3M ANTI-CARDIOLIPIN FAST(TM) TEST is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is 3M Diagnostic Systems, Inc.. The 510(k) number is K913054.

When did 3M ANTI-CARDIOLIPIN FAST(TM) TEST receive FDA 510(k) clearance?

3M ANTI-CARDIOLIPIN FAST(TM) TEST received FDA 510(k) clearance on 1991-11-27, under 510(k) number K913054.

Who is the listed applicant for 3M ANTI-CARDIOLIPIN FAST(TM) TEST?

The FDA 510(k) record lists 3M Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M ANTI-CARDIOLIPIN FAST(TM) TEST?

The FDA product code for 3M ANTI-CARDIOLIPIN FAST(TM) TEST is MID.

Related Clinical Trials

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.

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Other records listing 3M Diagnostic Systems, Inc. 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.

K9136533M ANTI-DSDNA FAST TESTK913892FASTTECH SYSTEM IIK911496FASTTECH SYSTEM 1

Related Devices (Code: MID)

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.

K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYPhadia US, Inc.K130528BIOPLEX 2200 APLS IGMBio-Rad LaboratoriesK120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAInova Diagnostics, Inc.K113020IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASImmco Diagnostics, Inc.K103834BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSBio-Rad Laboratories

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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