FDA Product Code
FDA Product Code GHM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7825
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K023656 | SICKLE-CHEX SOLUBILITY KIT | Streck Laboratories, Inc. | 2002-12-30 | Traditional | PDF ↗ |
| K013316 | SICKLE-CHEX | Streck Laboratories, Inc. | 2001-11-06 | Traditional | PDF ↗ |
| K960947 | SAS SICKLE CELL TEST | Sa Scientific, Inc. | 1996-07-01 | Traditional | PDF ↗ |
| K911981 | HEMOCARD HEMOGLOBIN S | Isolab, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K910430 | HEMOCARD-AS | Isolab, Inc. | 1991-04-15 | Traditional | PDF ↗ |
| K872217 | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT | Pacific Hemostasis | 1987-07-31 | Traditional | PDF ↗ |
| K860812 | SICKLE CELL REAGENT SET | Michclone Associates, Inc. | 1986-04-11 | Traditional | PDF ↗ |
| K860420 | SICKLE CELL REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-24 | Traditional | PDF ↗ |
| K854079 | THROMBO SCREEN SICKLE CELL ASSAY SET | Pacific Hemostasis | 1985-10-31 | Traditional | PDF ↗ |
| K842152 | SICKLING HEMOGLOBIN CONTROLS, NORMAL | Isolab, Inc. | 1984-09-09 | Traditional | PDF ↗ |
| K842955 | SICKLE-HEME A/S HETEROZYGOUS CONTROL | Michclone Associates, Inc. | 1984-08-09 | Traditional | PDF ↗ |
| K842368 | SICKLE CELL REAGENT SET | Livonia Diagnostics, Inc. | 1984-07-20 | Traditional | PDF ↗ |
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | Clinical Technology Corp. | 1984-04-13 | Traditional | PDF ↗ |
| K841170 | SICKLE HB ASSAY | Isolab, Inc. | 1984-04-04 | Traditional | PDF ↗ |
| K831871 | SICKLE-HEME A/S CONTROLS & A/A CONTROL | Anco Medical Reagents & Assoc. | 1983-07-28 | Traditional | PDF ↗ |
| K820642 | SICKLE-CHECK | Panmed, Inc. | 1982-04-14 | Traditional | PDF ↗ |
| K811828 | SICKLE CELL REAGENT SET | Anco Medical Reagents & Assoc. | 1981-08-12 | Traditional | PDF ↗ |
| K791971 | MONOJECT SICKLE CELL KIT | Sherwood Medical Co. | 1979-11-05 | Traditional | PDF ↗ |
Product code GHM · Class II · Hematology. Data: openFDA.