CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT— 510(k) K941168

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K941168 for CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1994-09-07. Applicant: Incstar Corp.. Device class: 1.

Clearance details

Applicant
Incstar Corp.
Product code
Code CHP
Device class
Class 1
Regulation
21 CFR 862.1260
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stillwater, MN, US
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