STATUS STIK, ACCUSIGN STIK
FDA 510(k) clearance K992068 · decided 1999-07-06
Clearance details
- K-number
- K992068
- Device name
- STATUS STIK, ACCUSIGN STIK
- Applicant
- Princeton BioMeditech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-18
- Decision date
- 1999-07-06
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- DKE
- Device class
- 2
- Regulation number
- 862.3870
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Monmouth Junction, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Princeton BioMeditech Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.