The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco Liquizyme Glucose/bun Standard 0124, 0200.
| Device ID | K880654 |
| 510k Number | K880654 |
| Device Name: | AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 |
| Classification | Calibrator, Surrogate |
| Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Contact | Jan Brownlee |
| Correspondent | Jan Brownlee AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
| Product Code | JIW |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-17 |
| Decision Date | 1988-06-07 |