The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Bicarbonate Reagents Product #7713 & #7714.
Device ID | K900420 |
510k Number | K900420 |
Device Name: | BICARBONATE REAGENTS PRODUCT #7713 & #7714 |
Classification | Ph Rate Measurement, Carbon-dioxide |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
Contact | C. K Owens |
Correspondent | C. K Owens AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
Product Code | JFL |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-30 |
Decision Date | 1990-03-01 |