The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Flow Pac Carbon Dioxide (co2) Reagents.
| Device ID | K870025 |
| 510k Number | K870025 |
| Device Name: | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS |
| Classification | Phenolphthalein Colorimetry, Carbon-dioxide |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Timothy J Belcastro |
| Correspondent | Timothy J Belcastro AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | KMS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-05 |
| Decision Date | 1987-03-13 |