Cleared Traditional

SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.

K890335 · Alpkem Corp. · Chemistry

Feb 1989

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K890335 is an FDA 510(k) clearance for the SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU., a Orthotoluidine, Glucose (Class II — Special Controls, product code CGE), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on February 17, 1989, 25 days after receiving the submission on January 23, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K890335 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 1989
Decision Date	February 17, 1989
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—