K100200 is an FDA 510(k) clearance for the ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138. This device is classified as a Colorimetry, Acetaminophen (Class II - Special Controls, product code LDP).
Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on August 2, 2010, 189 days after receiving the submission on January 25, 2010.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3030.
| 510(k) Number | K100200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2010 |
| Decision Date | August 02, 2010 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LDP — Colorimetry, Acetaminophen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3030 |