The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Acetazyme, Stanbio Acetaminophen Proc/test 0870.
| Device ID | K851278 |
| 510k Number | K851278 |
| Device Name: | ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 |
| Classification | Colorimetry, Acetaminophen |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | Howard C Leifheit |
| Correspondent | Howard C Leifheit STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-04-17 |