HEMOCARD HEMOGLOBIN S
FDA 510(k) clearance K911981 · decided 1991-10-09
Clearance details
- K-number
- K911981
- Device name
- HEMOCARD HEMOGLOBIN S
- Applicant
- Isolab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-03
- Decision date
- 1991-10-09
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- GHM
- Device class
- 2
- Regulation number
- 864.7825
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SICKLE-CHEX SOLUBILITY KIT (K023656) | Streck Laboratories, Inc. | 2002-12-30 |
| SICKLE-CHEX (K013316) | Streck Laboratories, Inc. | 2001-11-06 |
| SAS SICKLE CELL TEST (K960947) | Sa Scientific, Inc. | 1996-07-01 |
| HEMOCARD-AS (K910430) | Isolab, Inc. | 1991-04-15 |
| THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT (K872217) | Pacific Hemostasis | 1987-07-31 |
| SICKLE CELL REAGENT SET (K860812) | Michclone Associates, Inc. | 1986-04-11 |
| SICKLE CELL REAGENT SET (K860420) | Sterling Diagnostics, Inc. | 1986-02-24 |
| THROMBO SCREEN SICKLE CELL ASSAY SET (K854079) | Pacific Hemostasis | 1985-10-31 |
| SICKLING HEMOGLOBIN CONTROLS, NORMAL (K842152) | Isolab, Inc. | 1984-09-09 |
| SICKLE-HEME A/S HETEROZYGOUS CONTROL (K842955) | Michclone Associates, Inc. | 1984-08-09 |
| SICKLE CELL REAGENT SET (K842368) | Livonia Diagnostics, Inc. | 1984-07-20 |
| SICKLE-STAT HEMOGLOBIN S SCREEN KIT (K841272) | Clinical Technology Corp. | 1984-04-13 |
Recalls involving this device
No recalls on record reference this clearance.