ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
FDA 510(k) clearance K040327 · decided 2004-04-19
Clearance details
- K-number
- K040327
- Device name
- ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
- Applicant
- Accu-Stat Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-10
- Decision date
- 2004-04-19
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- MVO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Lake Forest, CA, 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 |
|---|---|---|
| AT HOME DRUG CUP, MODEL 9150X (K030447) | Phamatech | 2003-04-14 |
| LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET (K014192) | Princeton BioMeditech Corp. | 2002-05-23 |
| PEACE OF MIND HOME DRUG TEST (K013778) | Advantage Diagnostics Corp. | 2002-02-07 |
| AT HOME DRUG TEST, MODEL 9074 (K013409) | Phamatech, Inc. | 2001-12-06 |
| AT HOME DRUG TEST, MODEL 9064 (K013410) | Phamatech, Inc. | 2001-12-06 |
| AT HOME DRUG TEST, MODEL 9069 (K013412) | Phamatech, Inc. | 2001-12-06 |
| AT HOME DRUG TESTT, MODEL 9150 T (K010655) | Phamatech | 2001-04-05 |
| AT HOME DRUG TEST, MODEL 9078 T (K010654) | Phamatech | 2001-04-05 |
| AT HOME DRUG TEST, MODEL 9068 T (K010653) | Phamatech | 2001-04-05 |
| AT HOME DRUG TEST, MODEL 9083 T (K010646) | Phamatech | 2001-03-30 |
| MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 (K003858) | Phamatech | 2001-02-12 |
| DRUG STOP (K991465) | Texas Immunology, Inc. | 1999-12-10 |
Recalls involving this device
No recalls on record reference this clearance.