CARBON DIOXIDE REAGENT— 510(k) K896812

Name: FDA 510(k) clearance K896812
Creator: U.S. Food and Drug Administration
Published: 1990-02-23

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K896812 for CARBON DIOXIDE REAGENT, Substantially Equivalent on 1990-02-23. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1989-12-04
Decision date: 1990-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Pointe Scientific, Inc.,

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K070757 — MICROPROTEIN REAGENT SET2007-12-04
K062118 — POINTE 3602007-07-13
K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT2007-04-30
K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR2007-04-13
K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

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