The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Acetaminophen Test Set #0850.
| Device ID | K801014 |
| 510k Number | K801014 |
| Device Name: | STANBIO ACETAMINOPHEN TEST SET #0850 |
| Classification | Colorimetry, Acetaminophen |
| Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-28 |
| Decision Date | 1980-06-20 |