Antisera, Immunoperoxidase, Chlamydia Spp.
FDA product code LKH · Class I (low risk) · 21 CFR 866.3120 · Microbiology
8510(k) clearances
0PMA approvals
6recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910644 | Ipazyme (TM) Chlamydia Igg-IgaLKH · Traditional | Savyon Diagnostics , Ltd. | 03/19/1991SE |
| K901975 | Ipazyme(Tm) Chlamydia True Igm(Tm)LKH · Traditional | Savyon Diagnostics , Ltd. | 03/08/1991SE |
| K882674 | Immu-Mark(Tm) Chlamydia Igg/Iga KitLKH · Traditional | Icn Immunobiologicals | 08/15/1989SE |
| K893669 | Cellmatics Shlamydia Detection SystemLKH · Traditional | Difco Laboratories, Inc. | 06/23/1989SE |
| K852869 | Selecticult-ChlamydiaLKH · Traditional | Scott Laboratories, Inc. | 09/19/1985SE |
| K842151 | Chlamydiae Immunoperoxidase Test KitLKH · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 07/20/1984SE |
| K830688 | Combion Skin TestLKH · Traditional | Nicholas H. Maganias | 03/31/1983SE |
| K820390 | Histoset Immunoperoxidase Tissure KitLKH · Traditional | Immulok, Inc. | 04/14/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1140-2007 | Femoral Speed Block Size 12, Part/Catalog #800-01-370; positioning device included as…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | Encore Medical, Lp | 08/15/2006Terminated |
| Z-1139-2007 | Femoral Speed Block Size 10, Part/Catalog #800-01-369; positioning device included as…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | Encore Medical, Lp | 08/15/2006Terminated |
| Z-1138-2007 | Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | Encore Medical, Lp | 08/15/2006Terminated |
| Z-1137-2007 | Femoral Speed Block Size 6, Part/Catalog #800-01-367; positioning device included as…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | Encore Medical, Lp | 08/15/2006Terminated |
| Z-1136-2007 | Femoral Speed Block Size 4 Part/Catalog #800-01-366; positioning device included as part…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | Encore Medical, Lp | 08/15/2006Terminated |
| Z-1135-2007 | Femoral Speed Block Size 2, Part/Catalog #800-01-365; positioning device included as…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | Encore Medical, Lp | 08/15/2006Terminated |