Cleared Traditional

K780506 - CARBON DIOXIDE REAGENTS
(FDA 510(k) Clearance)

K780506 · Gamma Enterprises, Inc. · Chemistry device

May 1978

Decision

34d

Days

Class 2

Risk

K780506 is an FDA 510(k) clearance for the CARBON DIOXIDE REAGENTS. This device is classified as a Phenolphthalein Colorimetry, Carbon-dioxide (Class II - Special Controls, product code KMS).

Submitted by Gamma Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1978, 34 days after receiving the submission on March 30, 1978.

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

Submission Details

510(k) Number	K780506 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 30, 1978
Decision Date	May 03, 1978
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—