CLINITEK 200 SEMI-AUTOMATED URINALYSIS— 510(k) K842237

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K842237 for CLINITEK 200 SEMI-AUTOMATED URINALYSIS, Substantially Equivalent on 1984-08-15. Applicant: Miles Laboratories, Inc.. Device class: 1.

Clearance details

Applicant
Miles Laboratories, Inc.
Product code
Code KQO
Device class
Class 1
Regulation
21 CFR 862.2900
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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