Cleared Traditional

K843380 - ACID PHOSPHATASE ASSAY KIT
(FDA 510(k) Clearance)

K843380 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry

Sep 1984

Decision

23d

Days

Class 2

Risk

K843380 is an FDA 510(k) clearance for the ACID PHOSPHATASE ASSAY KIT, a Acid Phosphatase, Thymolphthale Inmonophosphate (Class II — Special Controls, product code CKE), submitted by Diagnostic Chemicals, Ltd. (Usa) (Canada, US). The FDA issued a Cleared decision on September 20, 1984, 23 days after receiving the submission on August 28, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number	K843380 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 1984
Decision Date	September 20, 1984
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—