POSID SAMPLER— 510(k) K860508

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K860508 for POSID SAMPLER, Substantially Equivalent on 1986-05-02. Applicant: Organon Teknika Corp.. Device class: 1.

Clearance details

Applicant
Organon Teknika Corp.
Product code
Code JQW
Device class
Class 1
Regulation
21 CFR 862.2750
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Oklahoma City, OK, US
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