Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GHM — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
38 daysmedian FDA review time
115 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023656 | SICKLE-CHEX SOLUBILITY KIT | Streck Laboratories, Inc. | 2002-12-30 | 61 | 0 |
| K013316 | SICKLE-CHEX | Streck Laboratories, Inc. | 2001-11-06 | 33 | 0 |
| K960947 | SAS SICKLE CELL TEST | Sa Scientific, Inc. | 1996-07-01 | 115 | 0 |
| K911981 | HEMOCARD HEMOGLOBIN S | Isolab, Inc. | 1991-10-09 | 159 | 0 |
| K910430 | HEMOCARD-AS | Isolab, Inc. | 1991-04-15 | 73 | 0 |
| K872217 | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT | Pacific Hemostasis | 1987-07-31 | 52 | 0 |
| K860812 | SICKLE CELL REAGENT SET | Michclone Associates, Inc. | 1986-04-11 | 38 | 3 |
| K860420 | SICKLE CELL REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-24 | 20 | 0 |
| K854079 | THROMBO SCREEN SICKLE CELL ASSAY SET | Pacific Hemostasis | 1985-10-31 | 24 | 1 |
| K842152 | SICKLING HEMOGLOBIN CONTROLS, NORMAL | Isolab, Inc. | 1984-09-09 | 102 | 0 |
| K842955 | SICKLE-HEME A/S HETEROZYGOUS CONTROL | Michclone Associates, Inc. | 1984-08-09 | 13 | 0 |
| K842368 | SICKLE CELL REAGENT SET | Livonia Diagnostics, Inc. | 1984-07-20 | 35 | 0 |
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | Clinical Technology Corp. | 1984-04-13 | 17 | 1 |
| K841170 | SICKLE HB ASSAY | Isolab, Inc. | 1984-04-04 | 16 | 0 |
| K831871 | SICKLE-HEME A/S CONTROLS & A/A CONTROL | Anco Medical Reagents & Assoc. | 1983-07-28 | 45 | 0 |
| K820642 | SICKLE-CHECK | Panmed, Inc. | 1982-04-14 | 37 | 0 |
| K811828 | SICKLE CELL REAGENT SET | Anco Medical Reagents & Assoc. | 1981-08-12 | 44 | 0 |
| K791971 | MONOJECT SICKLE CELL KIT | Sherwood Medical Co. | 1979-11-05 | 34 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda