Cleared Traditional

K770643 - CREATININE TEST, SUPER SEVENTEEN
(FDA 510(k) Clearance)

K770643 · Hycel, Inc. · Chemistry

Jun 1977

Decision

81d

Days

Class 2

Risk

K770643 is an FDA 510(k) clearance for the CREATININE TEST, SUPER SEVENTEEN, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1977, 81 days after receiving the submission on April 4, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number	K770643 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 1977
Decision Date	June 24, 1977
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—