NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT— 510(k) K911839

Substantially Equivalent

Pantex, Div. Bio-Analysis, Inc.

FDA 510(k) clearance K911839 for NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT, Substantially Equivalent on 1991-06-18. Applicant: Pantex, Div. Bio-Analysis, Inc..

Clearance details

Applicant: Pantex, Div. Bio-Analysis, Inc.
Product code: Code JLX
Advisory panel: Clinical Chemistry
Date received: 1991-04-25
Decision date: 1991-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

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