JBD · System, Analysis, Electrophoretic Hemoglobin
Hematology · 21 CFR 864.7440 · Class 2
Overview
| Product Code | JBD |
|---|---|
| Device Name | System, Analysis, Electrophoretic Hemoglobin |
| Regulation | 21 CFR 864.7440 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053571 | MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | Jun 30, 2006 | SESE |
| K032862 | INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | Feb 3, 2004 | SESE |
| K992199 | ACID HEMOGLOBIN KIT | Helena Laboratories | Sep 21, 1999 | SESE |
| K991362 | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) | Morax | Jun 21, 1999 | SESE |
| K982426 | SPIFE ALKALINE HEMOGLOBIN | Helena Laboratories | Dec 17, 1998 | SESE |
| K931503 | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) | Helena Laboratories | Aug 16, 1993 | SESE |
| K931465 | REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 | Helena Laboratories | Jul 6, 1993 | SESE |
| K901143 | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) | Helena Laboratories | May 23, 1990 | SESE |
| K830804 | LABILE REMOVING HEMOLYZING REAGENT | Corning Medical & Scientific | May 4, 1983 | SESE |
| K820518 | GELMAN GLYCO-PHORE BUFFER | Gelman Sciences, Inc. | Apr 9, 1982 | SESE |
| K813395 | CELLULOSE ACETATE-CITRATE AGAR HEMOGLO | Helena Laboratories | Dec 31, 1981 | SESE |
| K810919 | HEMOGLOBIN ELECTROPHORESIS CONTROL | Isolab, Inc. | Apr 23, 1981 | SESE |
| K810047 | AUTOPHOR 128 | Gelman Sciences, Inc. | Feb 5, 1981 | SESE |
| K802884 | CORNING NORMAL GLYCOSYLATED HEMOGLOBIN | Corning Medical & Scientific | Dec 22, 1980 | SESE |
| K802821 | PARAGON HEMOGLOBIN ELECTRO. REAG. KIT | Beckman Instruments, Inc. | Dec 11, 1980 | SESE |
| K800856 | A,FDA2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | Apr 29, 1980 | SESE |
| K800855 | A,FSC LYOPHILIZED HEMO CONTROL | Helena Laboratories | Apr 29, 1980 | SESE |
| K800854 | A,A2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | Apr 29, 1980 | SESE |
| K800853 | A,SA2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | Apr 29, 1980 | SESE |
| K791290 | BECKMAN B-4 TEB BUFFER KIT | Beckman Instruments, Inc. | Aug 3, 1979 | SESE |
Top Applicants
- Helena Laboratories — 11 clearances
- Corning Medical & Scientific — 3 clearances
- Beckman Instruments, Inc. — 2 clearances
- Electrophoresis Corp. of America — 2 clearances
- Gelman Sciences, Inc. — 2 clearances
