Product code GHM
- Device name
- Test, Sickle Cell
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7825
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023656 | SICKLE-CHEX SOLUBILITY KIT | Streck Laboratories, Inc. | 2002-12-30 |
| K013316 | SICKLE-CHEX | Streck Laboratories, Inc. | 2001-11-06 |
| K960947 | SAS SICKLE CELL TEST | Sa Scientific, Inc. | 1996-07-01 |
| K911981 | HEMOCARD HEMOGLOBIN S | Isolab, Inc. | 1991-10-09 |
| K910430 | HEMOCARD-AS | Isolab, Inc. | 1991-04-15 |
| K872217 | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT | Pacific Hemostasis | 1987-07-31 |
| K860812 | SICKLE CELL REAGENT SET | Michclone Associates, Inc. | 1986-04-11 |
| K860420 | SICKLE CELL REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-24 |
| K854079 | THROMBO SCREEN SICKLE CELL ASSAY SET | Pacific Hemostasis | 1985-10-31 |
| K842152 | SICKLING HEMOGLOBIN CONTROLS, NORMAL | Isolab, Inc. | 1984-09-09 |
| K842955 | SICKLE-HEME A/S HETEROZYGOUS CONTROL | Michclone Associates, Inc. | 1984-08-09 |
| K842368 | SICKLE CELL REAGENT SET | Livonia Diagnostics, Inc. | 1984-07-20 |
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | Clinical Technology Corp. | 1984-04-13 |
| K841170 | SICKLE HB ASSAY | Isolab, Inc. | 1984-04-04 |
| K831871 | SICKLE-HEME A/S CONTROLS & A/A CONTROL | Anco Medical Reagents & Assoc. | 1983-07-28 |
| K820642 | SICKLE-CHECK | Panmed, Inc. | 1982-04-14 |
| K811828 | SICKLE CELL REAGENT SET | Anco Medical Reagents & Assoc. | 1981-08-12 |
| K791971 | MONOJECT SICKLE CELL KIT | Sherwood Medical Co. | 1979-11-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860003629918 | Sickle-Heme | GREAT LAKES DIAGNOSTICS, INC. | 2021-12-13 |
| 00860003629925 | Sickle-Heme | GREAT LAKES DIAGNOSTICS, INC. | 2021-12-13 |
| 00860003629932 | Sickle-Heme | GREAT LAKES DIAGNOSTICS, INC. | 2021-12-13 |
| 00860003629949 | Sickle-Heme | GREAT LAKES DIAGNOSTICS, INC. | 2021-12-13 |
| 00860003629901 | Sickle-Heme | GREAT LAKES DIAGNOSTICS, INC. | 2021-12-13 |
| 00630414976365 | Dade® Sickle-Sol Test | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00630414976341 | Dade® Sickle-Sol Test | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00844509002024 | SICKLEDEX | STRECK, INC. | 2016-09-19 |
| 00844509002031 | SICKLEDEX | STRECK, INC. | 2016-09-19 |
| 00844509002048 | SICKLEDEX | STRECK, INC. | 2016-09-19 |
| 00844509000891 | Sickle-Chex | STRECK, INC. | 2016-09-19 |
| 00844509000884 | Sickle-Chex | STRECK, INC. | 2016-09-19 |
| 00845275000740 | Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 2016-09-16 |
| 00845275000757 | Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 2016-09-16 |
| 00845275000733 | Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 2016-07-19 |
| 00816057020003 | ASI Sickle Cell Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020010 | ASI Sickle Cell Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020027 | ASI Sickle Cell Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020034 | ASI Sickle Cell Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |