Cleared Traditional

K781004 - HMA URIC ACID TEST
(FDA 510(k) Clearance)

K781004 · Hycel, Inc. · Chemistry

Jul 1978

Decision

41d

Days

Class 1

Risk

K781004 is an FDA 510(k) clearance for the HMA URIC ACID TEST, a Acid, Uric, Uricase (colorimetric) (Class I — General Controls, product code KNK), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978, 41 days after receiving the submission on June 16, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number	K781004 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 1978
Decision Date	July 27, 1978
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—