D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN— 510(k) K892224

Name: FDA 510(k) clearance K892224
Creator: U.S. Food and Drug Administration
Published: 1989-06-16

Substantially Equivalent

Photec Diagnostics, Inc.

FDA 510(k) clearance K892224 for D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN, Substantially Equivalent on 1989-06-16. Applicant: Photec Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Photec Diagnostics, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1989-04-03
Decision date: 1989-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little Falls, NJ, US

Download summary PDF View on FDA.gov ↗

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K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

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K890027 — QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD1989-04-26
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