Panels › Microbiology › Product code LKH · Class 1
Antisera, Immunoperoxidase, Chlamydia Spp.
Regulation 866.3120
0510(k)s in 12 months (8 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in LKH
| Company | 510(k)s | Recalls |
|---|---|---|
| Encore Medical, Lp | 0 | 6 |
| Savyon Diagnostics , Ltd. | 2 | 0 |
| Bartels Immunodiagnostic Supplies, Inc. | 1 | 0 |
| Difco Laboratories, Inc. | 1 | 0 |
| Icn Immunobiologicals | 1 | 0 |
| Immulok, Inc. | 1 | 0 |
| Nicholas H. Maganias | 1 | 0 |
| Scott Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2007 | Encore Medical, Lp Femoral Speed Block Size 12, Part/Catalog #800-01-370; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Aus Terminated |
LKH | None listed |
| Aug 7, 2007 | Encore Medical, Lp Femoral Speed Block Size 10, Part/Catalog #800-01-369; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Aus Terminated |
LKH | None listed |
| Aug 7, 2007 | Encore Medical, Lp Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Aust Terminated |
LKH | None listed |
| Aug 7, 2007 | Encore Medical, Lp Femoral Speed Block Size 6, Part/Catalog #800-01-367; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Aust Terminated |
LKH | None listed |
| Aug 7, 2007 | Encore Medical, Lp Femoral Speed Block Size 4 Part/Catalog #800-01-366; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Austi Terminated |
LKH | None listed |
| Aug 7, 2007 | Encore Medical, Lp Femoral Speed Block Size 2, Part/Catalog #800-01-365; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Aust Terminated |
LKH | None listed |
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