The following data is part of a premarket notification filed by Hyland Therapeutic Div., Travenol Laboratories with the FDA for Q-pak Therapeutic Drug Monit. Control S.
| Device ID | K810078 |
| 510k Number | K810078 |
| Device Name: | Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S |
| Classification | Drug Mixture Control Materials |
| Applicant | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-13 |
| Decision Date | 1981-02-02 |