CRACK-IT CHAP SCREEN
FDA 510(k) clearance K874389 · decided 1989-02-07
Clearance details
- K-number
- K874389
- Device name
- CRACK-IT CHAP SCREEN
- Applicant
- Sakers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-10-27
- Decision date
- 1989-02-07
- Days to decision
- 469 days
- Clearance type
- Traditional
- Product code
- DMN
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Westville, 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 |
|---|---|---|
| QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070) (K972618) | Phamatech | 1997-08-08 |
Recalls involving this device
No recalls on record reference this clearance.