HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
FDA 510(k) clearance K991362 · decided 1999-06-21
Clearance details
- K-number
- K991362
- Device name
- HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
- Applicant
- Morax
- Decision
- Substantially Equivalent
- Date received
- 1999-04-14
- Decision date
- 1999-06-21
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- JBD
- Device class
- 2
- Regulation number
- 864.7440
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Chelsea, MI, 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 |
|---|---|---|
| MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K053571) | Interlab S.R.L. | 2006-06-30 |
| INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K032862) | Interlab S.R.L. | 2004-02-03 |
| ACID HEMOGLOBIN KIT (K992199) | Helena Laboratories | 1999-09-21 |
| SPIFE ALKALINE HEMOGLOBIN (K982426) | Helena Laboratories | 1998-12-17 |
| REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K931503) | Helena Laboratories | 1993-08-16 |
| REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 (K931465) | Helena Laboratories | 1993-07-06 |
| REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K901143) | Helena Laboratories | 1990-05-23 |
| LABILE REMOVING HEMOLYZING REAGENT (K830804) | Corning Medical & Scientific | 1983-05-04 |
| GELMAN GLYCO-PHORE BUFFER (K820518) | Gelman Sciences, Inc. | 1982-04-09 |
| CELLULOSE ACETATE-CITRATE AGAR HEMOGLO (K813395) | Helena Laboratories | 1981-12-31 |
| HEMOGLOBIN ELECTROPHORESIS CONTROL (K810919) | Isolab, Inc. | 1981-04-23 |
| AUTOPHOR 128 (K810047) | Gelman Sciences, Inc. | 1981-02-05 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leo recall (Z-0073-2007) | Sebia, Inc. | 2006-10-25 |