MINI S.F.T. (URINE PRESERVATIVE)
FDA 510(k) clearance K943466 · decided 1995-05-24
Clearance details
- K-number
- K943466
- Device name
- MINI S.F.T. (URINE PRESERVATIVE)
- Applicant
- Cambridge Diagnostic Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-15
- Decision date
- 1995-05-24
- Days to decision
- 343 days
- Clearance type
- Traditional
- Product code
- LXG
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Ft. Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cambridge Diagnostic Products
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.
| Record | Firm | Date |
|---|---|---|
| PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM (K021927) | Biomet, Inc. | 2002-07-12 |
| MAGNET PAD (K896802) | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 |
Recalls involving this device
No recalls on record reference this clearance.