The following data is part of a premarket notification filed by Verichem Laboratories, Inc. with the FDA for Therapeutic Drug Standard.
| Device ID | K880705 |
| 510k Number | K880705 |
| Device Name: | THERAPEUTIC DRUG STANDARD |
| Classification | Calibrators, Drug Mixture |
| 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 | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-22 |
| Decision Date | 1988-05-31 |