Panels › Clinical Chemistry › Product code LBR · Class 1
Ldl & Vldl Precipitation, Hdl
Regulation 862.1475
0510(k)s in 12 months (66 all time)
0recalls in 12 months (11 all time)
10recalls that name a 510(k)
Top companies in LBR
| Company | 510(k)s | Recalls |
|---|---|---|
| Pointe Scientific, Inc., | 3 | 5 |
| Diagnostic Chemicals , Ltd. | 3 | 0 |
| Genzyme Corp. | 3 | 0 |
| Merchant House Scientific | 3 | 0 |
| Stanbio Laboratory, Inc | 0 | 3 |
| American Monitor Corp. | 2 | 0 |
| Boehringer Mannheim Corp. | 2 | 0 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 0 |
| Preventive Diagnostics Corp. | 2 | 0 |
| Reference Diagnostics, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 1985 | K852350 | HDL CHOLESTEROL PRETREATMENT American Monitor Corp. | LBR |
| Nov 2, 1984 | K843894 | HDL PRECIPATATING REAGENT SET Livonia Diagnostics, Inc. | LBR |
| Feb 13, 1984 | K834251 | HDL CHOLESTEROL PRETREATMENT American Monitor Corp. | LBR |
| Feb 9, 1984 | K833160 | HDL EZ-TAB Preventive Diagnostics Corp. | LBR |
| Jan 13, 1984 | K833431 | HDL EX-SEP PRECIPITATING REAGENT Preventive Diagnostics Corp. | LBR |
| Mar 21, 1983 | K830207 | RAICHEM HDL-CHOLESTEROL REAGENT Reagents Applications, Inc. | LBR |
| Jul 13, 1982 | K821203 | HDL PRECIPITANT REAGENT SET Omega Medical Electronics | LBR |
| Dec 3, 1981 | K812839 | HDL CHOLESTEROL REAGENT SET Anco Medical Reagents & Assoc. | LBR |
| Sep 24, 1981 | K812574 | HDL CHOLESTEROL REAGENT Pointe Scientific, Inc., | LBR |
| May 14, 1980 | K800996 | HDL REAGENT Gilford Diagnostics | LBR |
| Dec 7, 1979 | K792313 | CHOL-HDL TEST, HIGH LIPO. CHOL TEST Sclavo, Inc. | LBR |
| Jun 28, 1979 | K790865 | LANCER HDL SEPARATION KIT Sherwood Medical Co. | LBR |
| May 3, 1979 | K790372 | H-D-EL General Diagnostics | LBR |
| Apr 4, 1979 | K790329 | A-GENT-HDL REAGENT Abbott Laboratories | LBR |
| Aug 14, 1978 | K781093 | HDL CENTRIFIKIT Beckman Instruments, Inc. | LBR |
| May 19, 1978 | K780542 | ALFATEST Panmed, Inc. | LBR |
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