UROPAPER EIKEN GK— 510(k) K932363

Substantially Equivalent

Tanabe U.S.A., Inc.

FDA 510(k) clearance K932363 for UROPAPER EIKEN GK, Substantially Equivalent on 1993-11-16. Applicant: Tanabe U.S.A., Inc.. Device class: 2.

Clearance details

Applicant: Tanabe U.S.A., Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1993-04-19
Decision date: 1993-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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