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FDA 510(k)

3M ANTI-DSDNA FAST TEST

K-Number: K913653 · 1991-11-07

Applicant3M Diagnostic Systems, Inc.
Decision Date1991-11-07
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

3M ANTI-DSDNA FAST 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 1991-11-07 under 510(k) number K913653. The device is classified under product code LRM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M ANTI-DSDNA FAST TEST?

3M ANTI-DSDNA FAST TEST is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is 3M Diagnostic Systems, Inc.. The 510(k) number is K913653.

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

3M ANTI-DSDNA FAST TEST received FDA 510(k) clearance on 1991-11-07, under 510(k) number K913653.

Who is the listed applicant for 3M ANTI-DSDNA FAST 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-DSDNA FAST TEST?

The FDA product code for 3M ANTI-DSDNA FAST TEST is LRM.

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.

K9130543M ANTI-CARDIOLIPIN FAST(TM) TESTK913892FASTTECH SYSTEM IIK911496FASTTECH SYSTEM 1

Related Devices (Code: LRM)

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.

K101319IMMULISA DSDNA ANTIBODY ELISAImmco Diagnostics, Inc.K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)Euroimmun Us, Inc.K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.K040811VARELISA SSDNA ANTIBODIES, MODEL 14896Pharmacia Deutschland GmbHK001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.K000477MDI DS-DNA TESTMicro Detect, 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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