50NG/ML COCAINE METABOLITE CALIBRATOR— 510(k) K972835
Substantially EquivalentDiagnostic Reagents, Inc.
FDA 510(k) clearance K972835 for 50NG/ML COCAINE METABOLITE CALIBRATOR, Substantially Equivalent on 1997-08-28. Applicant: Diagnostic Reagents, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Reagents, Inc.
- 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
- Traditional
- Location
- Sunnyvale, CA, US
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More clearances from Diagnostic Reagents, Inc.
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