Cleared Traditional

BL BILIRUBINOMETER

K790608 · Advanced Instruments, Inc. · Chemistry

Jun 1979

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K790608 is an FDA 510(k) clearance for the BL BILIRUBINOMETER, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Advanced Instruments, Inc.. The FDA issued a Cleared decision on June 15, 1979, 78 days after receiving the submission on March 29, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number	K790608 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 1979
Decision Date	June 15, 1979
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—