QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
FDA 510(k) clearance K981687 · decided 1998-06-03
Clearance details
- K-number
- K981687
- Device name
- QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
- Applicant
- Phamatech
- Decision
- Substantially Equivalent
- Date received
- 1998-05-13
- Decision date
- 1998-06-03
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- JXM
- Device class
- 2
- Regulation number
- 862.3170
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.