The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Flow Pac Total Iron Reagents:2183,2349,2312,014339.
Device ID | K871284 |
510k Number | K871284 |
Device Name: | FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339 |
Classification | Photometric Method, Iron (non-heme) |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
Contact | J. A Levey |
Correspondent | J. A Levey AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
Product Code | JIY |
CFR Regulation Number | 862.1410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-31 |
Decision Date | 1987-04-08 |