NAPHTHYL PHOSPHATE, ACID PHOSPHATASE— 510(k) K863832

Name: FDA 510(k) clearance K863832
Creator: U.S. Food and Drug Administration
Published: 1986-12-16

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K863832 for NAPHTHYL PHOSPHATE, ACID PHOSPHATASE, Substantially Equivalent on 1986-12-16. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1986-09-30
Decision date: 1986-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

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K931701 — IMMULITE PAP1994-01-27
K925377 — IMX PAP1993-01-13

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K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

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