Panels › Clinical Chemistry › Product code LXG · Class 1
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Regulation 862.2050
0510(k)s in 12 months (3 all time)
1recalls in 12 months (28 all time)
4recalls that name a 510(k)
Top companies in LXG
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics Inc. | 0 | 10 |
| Beckman Coulter Inc | 0 | 5 |
| Biomedical Polymers, Inc. | 0 | 2 |
| Dynex Technologies, Inc. | 0 | 2 |
| Roche Diagnostics Operations, Inc. | 0 | 2 |
| Sysmex America, Inc. | 0 | 2 |
| Biomerieux Inc | 0 | 1 |
| Biomet, Inc. | 1 | 0 |
| Cambridge Diagnostic Products, Inc. | 1 | 0 |
| Helena Laboratories, Corp. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 12, 2002 | K021927 | PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM Biomet, Inc. | LXG |
| May 24, 1995 | K943466 | MINI S.F.T. (URINE PRESERVATIVE) Cambridge Diagnostic Products, Inc. | LXG |
| Dec 27, 1989 | K896802 | MAGNET PAD Westmark, Sterile Packing Systems, Inc. (Sps) | LXG |
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