MAGNET PAD
FDA 510(k) clearance K896802 · decided 1989-12-27
Clearance details
- K-number
- K896802
- Device name
- MAGNET PAD
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
- Decision
- Substantially Equivalent
- Date received
- 1989-12-01
- Decision date
- 1989-12-27
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- LXG
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Grand Rapids, MI, 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 |
|---|---|---|
| PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM (K021927) | Biomet, Inc. | 2002-07-12 |
| MINI S.F.T. (URINE PRESERVATIVE) (K943466) | Cambridge Diagnostic Products, Inc. | 1995-05-24 |
Recalls involving this device
No recalls on record reference this clearance.