510(k) K870025

AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS by American Research Products Co. — Product Code KMS

K870025 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS". The FDA issued a decision of Substantially Equivalent on March 13, 1987. The device falls under product code KMS (Phenolphthalein Colorimetry, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. American Research Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1987
Date Received
January 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phenolphthalein Colorimetry, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type