QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)
FDA 510(k) clearance K972618 · decided 1997-08-08
Clearance details
- K-number
- K972618
- Device name
- QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)
- Applicant
- Phamatech
- Decision
- Substantially Equivalent
- Date received
- 1997-07-11
- Decision date
- 1997-08-08
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DMN
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Diego, 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 |
|---|---|---|
| CRACK-IT CHAP SCREEN (K874389) | Sakers, Inc. | 1989-02-07 |
Recalls involving this device
No recalls on record reference this clearance.