Cleared Traditional

K802080 - BAKER DIAG. ULTRARATE CHLORIDE KIT
(FDA 510(k) Clearance)

K802080 · J.T. Baker Chemical Co. · Chemistry

Oct 1980

Decision

43d

Days

Class 2

Risk

K802080 is an FDA 510(k) clearance for the BAKER DIAG. ULTRARATE CHLORIDE KIT. This device is classified as a Coulometric, Chloride (Class II — Special Controls, product code JFS).

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980, 43 days after receiving the submission on August 28, 1980.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number	K802080 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 1980
Decision Date	October 10, 1980
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—