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FDA 510(k)

FASTTECH SYSTEM 1

K-Number: K911496 · 1991-06-24

Applicant3M Diagnostic Systems, Inc.
Decision Date1991-06-24
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FASTTECH SYSTEM 1 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 1991-06-24 under 510(k) number K911496. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTTECH SYSTEM 1?

FASTTECH SYSTEM 1 is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is 3M Diagnostic Systems, Inc.. The 510(k) number is K911496.

When did FASTTECH SYSTEM 1 receive FDA 510(k) clearance?

FASTTECH SYSTEM 1 received FDA 510(k) clearance on 1991-06-24, under 510(k) number K911496.

Who is the listed applicant for FASTTECH SYSTEM 1?

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 FASTTECH SYSTEM 1?

The FDA product code for FASTTECH SYSTEM 1 is LSR.

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) TESTK9136533M ANTI-DSDNA FAST TESTK913892FASTTECH SYSTEM II

Related Devices (Code: LSR)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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