K851278 is an FDA 510(k) clearance for the ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870. This device is classified as a Colorimetry, Acetaminophen (Class II - Special Controls, product code LDP).
Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on April 17, 1985, 16 days after receiving the submission on April 1, 1985.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3030.
| 510(k) Number | K851278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1985 |
| Decision Date | April 17, 1985 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LDP — Colorimetry, Acetaminophen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3030 |