The following data is part of a premarket notification filed by Verichem Laboratories, Inc. with the FDA for Multi-enzyme Linearity Solution.
| Device ID | K880266 |
| 510k Number | K880266 |
| Device Name: | MULTI-ENZYME LINEARITY SOLUTION |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | VERICHEM LABORATORIES, INC. 3226 PAWTUCKET AVE. SUITE #1 East Providence, RI 02915 |
| Contact | Anthony J Dimonte |
| Correspondent | Anthony J Dimonte VERICHEM LABORATORIES, INC. 3226 PAWTUCKET AVE. SUITE #1 East Providence, RI 02915 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-22 |
| Decision Date | 1988-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852553007131 | K880266 | 000 |
| 00852553007056 | K880266 | 000 |
| 00852553007049 | K880266 | 000 |