Cleared Traditional

CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4

K961807 · Ciba Corning Diagnostics Corp. · Chemistry

Jul 1996

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K961807 is an FDA 510(k) clearance for the CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4, a Control, Hematocrit (Class II — Special Controls, product code GLK), submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on July 26, 1996, 77 days after receiving the submission on May 10, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K961807 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 1996
Decision Date	July 26, 1996
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF