Product code JBD
- Device name
- System, Analysis, Electrophoretic Hemoglobin
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7440
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053571 | MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | 2006-06-30 |
| K032862 | INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | 2004-02-03 |
| K992199 | ACID HEMOGLOBIN KIT | Helena Laboratories | 1999-09-21 |
| K991362 | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) | Morax | 1999-06-21 |
| K982426 | SPIFE ALKALINE HEMOGLOBIN | Helena Laboratories | 1998-12-17 |
| K931503 | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) | Helena Laboratories | 1993-08-16 |
| K931465 | REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 | Helena Laboratories | 1993-07-06 |
| K901143 | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) | Helena Laboratories | 1990-05-23 |
| K830804 | LABILE REMOVING HEMOLYZING REAGENT | Corning Medical & Scientific | 1983-05-04 |
| K820518 | GELMAN GLYCO-PHORE BUFFER | Gelman Sciences, Inc. | 1982-04-09 |
| K813395 | CELLULOSE ACETATE-CITRATE AGAR HEMOGLO | Helena Laboratories | 1981-12-31 |
| K810919 | HEMOGLOBIN ELECTROPHORESIS CONTROL | Isolab, Inc. | 1981-04-23 |
| K810047 | AUTOPHOR 128 | Gelman Sciences, Inc. | 1981-02-05 |
| K802884 | CORNING NORMAL GLYCOSYLATED HEMOGLOBIN | Corning Medical & Scientific | 1980-12-22 |
| K802821 | PARAGON HEMOGLOBIN ELECTRO. REAG. KIT | Beckman Instruments, Inc. | 1980-12-11 |
| K800853 | A,SA2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | 1980-04-29 |
| K800854 | A,A2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | 1980-04-29 |
| K800855 | A,FSC LYOPHILIZED HEMO CONTROL | Helena Laboratories | 1980-04-29 |
| K800856 | A,FDA2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | 1980-04-29 |
| K791008 | ECA (SPECIAL) HEME BUFFER | Electrophoresis Corp. of America | 1979-08-03 |
| K791290 | BECKMAN B-4 TEB BUFFER KIT | Beckman Instruments, Inc. | 1979-08-03 |
| K790944 | CITRATE AGAR GEL AND BUFFER SET | Corning Medical & Scientific | 1979-06-28 |
| K781119 | ECA HEME BUFFER | Electrophoresis Corp. of America | 1978-08-14 |
| K780807 | HBF-QUIPLATE METHODOLOGY | Helena Laboratories | 1978-06-02 |
| K780163 | REDI-DISC HEMOGLOBIN GEL TUBE KIT | Miles Laboratories, Inc. | 1978-03-27 |
| K771649 | HEMOGLOBIN A2 TESTING SYSTEM | Isolab, Inc. | 1977-10-07 |
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| M52523220 | SPIFE 4000 Acid Hemoglobin Kit | HELENA LABORATORIES CORPORATION | 2017-01-30 |
| M52523200 | SPIFE 4000 Alkaline Hemoglobin Gel Kit | HELENA LABORATORIES CORPORATION | 2017-01-30 |
| M5255526060 | SPIFE Acid Hemoglobin Kit | HELENA LABORATORIES CORPORATION | 2017-01-20 |
| M5255519770 | SPIFE Alkaline Hemoglobin Gel Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52524000 | Titan IV Citrate Agar Plate | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52558050 | Electra HR Buffer | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52558020 | Supre-Heme Buffer | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M5255521340 | QuickGel Applicator Blade and Shallow Well Cups | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M5255521100 | QuickGel Alkaline Hemoglobin Gel Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M5255520070 | QuickGel Acid Hemoglobin 10/20 Gel Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52530210 | Titan III-H Cellulose Acetate Plate | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M5255519510 | SPIFE Acid Hemoglobin Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553310 | AFSC Hemo Control | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553300 | AFSA2 Hemo Control | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553290 | ASA2 Hemo Control | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553280 | AA2 Hemo Control | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52534280 | SPIFE Hemoglobin IEF Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52534260 | QuickGel Accessory Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52530220 | Titan III-H Cellulose Acetate Plate | HELENA LABORATORIES CORPORATION | 2016-09-07 |