TERUMO SENSIBEAD EIA PROGESTERONE KIT— 510(k) K881693

Name: FDA 510(k) clearance K881693
Creator: U.S. Food and Drug Administration
Published: 1988-06-07

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K881693 for TERUMO SENSIBEAD EIA PROGESTERONE KIT, Substantially Equivalent on 1988-06-07. Applicant: Terumo Medical Corp.. Device class: 2.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1988-04-19
Decision date: 1988-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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