The following data is part of a premarket notification filed by Supelco, Inc. with the FDA for 4-9295 Barbiturates Test Mix.
| Device ID | K871174 |
| 510k Number | K871174 |
| Device Name: | 4-9295 BARBITURATES TEST MIX |
| Classification | Calibrators, Drug Mixture |
| Applicant | SUPELCO, INC. SUPELCO PARK Bellefonte, PA 16823 -0048 |
| Contact | Lloyd A Witting,phd |
| Correspondent | Lloyd A Witting,phd SUPELCO, INC. SUPELCO PARK Bellefonte, PA 16823 -0048 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-24 |
| Decision Date | 1987-06-11 |