Cleared Traditional

HEMOTOLOGY PRODU&TS (5 IN ALL)

K770803 · Hycel, Inc. · Chemistry

Jul 1977

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K770803 is an FDA 510(k) clearance for the HEMOTOLOGY PRODU&TS (5 IN ALL), a Cyanomethemoglobin (Class II — Special Controls, product code GKK), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 5, 1977, 64 days after receiving the submission on May 2, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number	K770803 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 1977
Decision Date	July 05, 1977
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—