Cleared Traditional

K991387 - ELAN ALKALINE PHOSPHATE REAGENT KIT
(FDA 510(k) Clearance)

K991387 · Elan Holdings, Inc. · Chemistry

May 1999

Decision

28d

Days

Class 2

Risk

K991387 is an FDA 510(k) clearance for the ELAN ALKALINE PHOSPHATE REAGENT KIT, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on May 19, 1999, 28 days after receiving the submission on April 21, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K991387 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 1999
Decision Date	May 19, 1999
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF