RAPID TOX CUP
FDA 510(k) clearance K073078 · decided 2008-05-30
Clearance details
- K-number
- K073078
- Device name
- RAPID TOX CUP
- Applicant
- American Bio Medica Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-31
- Decision date
- 2008-05-30
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- LAG
- Device class
- 2
- Regulation number
- 862.3610
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Logan Township, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP (K062575) | Princeton BioMeditech Corp. | 2007-11-26 |
| ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ (K990786) | Princeton BioMeditech Corp. | 1999-03-26 |
| ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ (K983501) | Princeton BioMeditech Corp. | 1998-12-18 |
Recalls involving this device
No recalls on record reference this clearance.