The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Barbiturate Test Set #0550-050.
| Device ID | K823237 |
| 510k Number | K823237 |
| Device Name: | BARBITURATE TEST SET #0550-050 |
| Classification | Mercury Dithiazone, Colorimetry, Barbiturate |
| Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DJN |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-01 |
| Decision Date | 1982-11-29 |