TOTAL IRON (NITRO-PAPS) REAGENT SET— 510(k) K961588

Name: FDA 510(k) clearance K961588
Creator: U.S. Food and Drug Administration
Published: 1996-11-18

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K961588 for TOTAL IRON (NITRO-PAPS) REAGENT SET, Substantially Equivalent on 1996-11-18. Applicant: Pointe Scientific, Inc.,. Device class: 1.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1996-04-24
Decision date: 1996-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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