Cleared Traditional

K870025 - AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
(FDA 510(k) Clearance)

K870025 · American Research Products Co. · Chemistry device

Mar 1987

Decision

67d

Days

Class 2

Risk

K870025 is an FDA 510(k) clearance for the AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS. This device is classified as a Phenolphthalein Colorimetry, Carbon-dioxide (Class II - Special Controls, product code KMS).

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on March 13, 1987, 67 days after receiving the submission on January 5, 1987.

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

Submission Details

510(k) Number	K870025 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 05, 1987
Decision Date	March 13, 1987
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—