Submission Details
| 510(k) Number | K100200 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
Aug 2010
Decision
189d
Days
Class 2
Risk
About This 510(k) Submission
K100200 is an FDA 510(k) clearance for the ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138, a Colorimetry, Acetaminophen (Class II — Special Controls, product code LDP), submitted by Siemens Healthcare Diagnostics (New York, 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 review panel. Regulated under 21 CFR 862.3030.
Device Classification
| Product Code | LDP — Colorimetry, Acetaminophen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3030 |
Manufacturer
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