The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Liquizyme Co2reagent Set.
Device ID | K820388 |
510k Number | K820388 |
Device Name: | LIQUIZYME CO2REAGENT SET |
Classification | Ph Rate Measurement, Carbon-dioxide |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JFL |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-10 |
Decision Date | 1982-03-08 |