'RAPID ONE' - PROPOXYPHENE TEST— 510(k) K030835
Substantially EquivalentAmerican Bio Medica Corp.
FDA 510(k) clearance K030835 for 'RAPID ONE' - PROPOXYPHENE TEST, Substantially Equivalent on 2003-05-22. Applicant: American Bio Medica Corp.. Device class: 2.
Clearance details
- Applicant
- American Bio Medica Corp.
- Product code
- Code JXN
- Device class
- Class 2
- Regulation
- 21 CFR 862.3700
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
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