PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS— 510(k) K033246
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K033246 for PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS, Substantially Equivalent on 2003-12-02. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code DLJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.