'RAPIDTEC' 5A MULTIPLE DIP TEST— 510(k) K021114
Substantially EquivalentAmerican Bio Medica Corp.
FDA 510(k) clearance K021114 for 'RAPIDTEC' 5A MULTIPLE DIP TEST, Substantially Equivalent on 2002-07-23. Applicant: American Bio Medica Corp.. Device class: 2.
Clearance details
- Applicant
- American Bio Medica Corp.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
Recent devices under product code DKZ
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