Panels › Hematology › Product code GHM · Class 2
Test, Sickle Cell
Regulation 864.7825
0510(k)s in 12 months (18 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in GHM
| Company | 510(k)s | Recalls |
|---|---|---|
| Michclone Associates, Inc. | 2 | 3 |
| Isolab, Inc. | 4 | 0 |
| Anco Medical Reagents & Assoc. | 2 | 0 |
| Pacific Hemostasis | 2 | 0 |
| Streck Laboratories, Inc. | 2 | 0 |
| Chembio Diagnostic System Inc | 0 | 1 |
| Clinical Technology Corp. | 1 | 0 |
| Fisher Diagnostic, A Company of Fisher Scientific LLC | 0 | 1 |
| Livonia Diagnostics, Inc. | 1 | 0 |
| Panmed, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 30, 2002 | K023656 | SICKLE-CHEX SOLUBILITY KIT Streck Laboratories, Inc. | GHM |
| Nov 6, 2001 | K013316 | SICKLE-CHEX Streck Laboratories, Inc. | GHM |
| Jul 1, 1996 | K960947 | SAS SICKLE CELL TEST Sa Scientific, Inc. | GHM |
| Oct 9, 1991 | K911981 | HEMOCARD HEMOGLOBIN S Isolab, Inc. | GHM |
| Apr 15, 1991 | K910430 | HEMOCARD-AS Isolab, Inc. | GHM |
| Jul 31, 1987 | K872217 | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT Pacific Hemostasis | GHM |
| Apr 11, 1986 | K860812 | SICKLE CELL REAGENT SET Michclone Associates, Inc. | GHM |
| Feb 24, 1986 | K860420 | SICKLE CELL REAGENT SET Sterling Diagnostics, Inc. | GHM |
| Oct 31, 1985 | K854079 | THROMBO SCREEN SICKLE CELL ASSAY SET Pacific Hemostasis | GHM |
| Sep 9, 1984 | K842152 | SICKLING HEMOGLOBIN CONTROLS, NORMAL Isolab, Inc. | GHM |
| Aug 9, 1984 | K842955 | SICKLE-HEME A/S HETEROZYGOUS CONTROL Michclone Associates, Inc. | GHM |
| Jul 20, 1984 | K842368 | SICKLE CELL REAGENT SET Livonia Diagnostics, Inc. | GHM |
| Apr 13, 1984 | K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT Clinical Technology Corp. | GHM |
| Apr 4, 1984 | K841170 | SICKLE HB ASSAY Isolab, Inc. | GHM |
| Jul 28, 1983 | K831871 | SICKLE-HEME A/S CONTROLS & A/A CONTROL Anco Medical Reagents & Assoc. | GHM |
| Apr 14, 1982 | K820642 | SICKLE-CHECK Panmed, Inc. | GHM |
| Aug 12, 1981 | K811828 | SICKLE CELL REAGENT SET Anco Medical Reagents & Assoc. | GHM |
| Nov 5, 1979 | K791971 | MONOJECT SICKLE CELL KIT Sherwood Medical Co. | GHM |
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