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FDA 510(k)

STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)

K-Number: K965166 · 1997-02-04

ApplicantSpecialized Assays, Inc.
Decision Date1997-02-04
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) is the device name listed in this FDA 510(k) record. The listed applicant is Specialized Assays, Inc.. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K965166. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)?

STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Specialized Assays, Inc.. The 510(k) number is K965166.

When did STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) receive FDA 510(k) clearance?

STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) received FDA 510(k) clearance on 1997-02-04, under 510(k) number K965166.

Who is the listed applicant for STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)?

The FDA 510(k) record lists Specialized Assays, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)?

The FDA product code for STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) is JJT.

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Other records listing Specialized Assays, 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.

K965169STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)K965168STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)

Related Devices (Code: JJT)

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.

K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-Rad

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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