Cleared Traditional

WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6

K964278 · Clinical Controls, Inc. · Chemistry

Nov 1996

Decision

25d

Days

Class 1

Risk

About This 510(k) Submission

K964278 is an FDA 510(k) clearance for the WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on November 22, 1996, 25 days after receiving the submission on October 28, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K964278 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 1996
Decision Date	November 22, 1996
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement