Cleared Traditional

K802162 - CO2 COLOR REAGENT & CO2 SAMPLE DILUENT
(FDA 510(k) Clearance)

K802162 · Panmed, Inc. · Chemistry device

Oct 1980

Decision

32d

Days

Class 2

Risk

K802162 is an FDA 510(k) clearance for the CO2 COLOR REAGENT & CO2 SAMPLE DILUENT. This device is classified as a Phenolphthalein Colorimetry, Carbon-dioxide (Class II - Special Controls, product code KMS).

Submitted by Panmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980, 32 days after receiving the submission on September 8, 1980.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number	K802162 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 08, 1980
Decision Date	October 10, 1980
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—