FDA Product Code
FDA Product Code JBD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7440
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K053571 | MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | 2006-06-30 | Traditional | PDF ↗ |
| K032862 | INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | 2004-02-03 | Traditional | PDF ↗ |
| K992199 | ACID HEMOGLOBIN KIT | Helena Laboratories | 1999-09-21 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K982426 | SPIFE ALKALINE HEMOGLOBIN | Helena Laboratories | 1998-12-17 | Traditional | PDF ↗ |
| K931503 | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) | Helena Laboratories | 1993-08-16 | Traditional | PDF ↗ |
| K931465 | REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 | Helena Laboratories | 1993-07-06 | Traditional | PDF ↗ |
| K901143 | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) | Helena Laboratories | 1990-05-23 | Traditional | PDF ↗ |
| K830804 | LABILE REMOVING HEMOLYZING REAGENT | Corning Medical & Scientific | 1983-05-04 | Traditional | PDF ↗ |
| K820518 | GELMAN GLYCO-PHORE BUFFER | Gelman Sciences, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K813395 | CELLULOSE ACETATE-CITRATE AGAR HEMOGLO | Helena Laboratories | 1981-12-31 | Traditional | PDF ↗ |
| K810919 | HEMOGLOBIN ELECTROPHORESIS CONTROL | Isolab, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K810047 | AUTOPHOR 128 | Gelman Sciences, Inc. | 1981-02-05 | Traditional | PDF ↗ |
| K802884 | CORNING NORMAL GLYCOSYLATED HEMOGLOBIN | Corning Medical & Scientific | 1980-12-22 | Traditional | PDF ↗ |
| K802821 | PARAGON HEMOGLOBIN ELECTRO. REAG. KIT | Beckman Instruments, Inc. | 1980-12-11 | Traditional | PDF ↗ |
| K800854 | A,A2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | 1980-04-29 | Traditional | PDF ↗ |
| K800856 | A,FDA2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | 1980-04-29 | Traditional | PDF ↗ |
| K800853 | A,SA2 LYOPHILIZED HEMO CONTROL | Helena Laboratories | 1980-04-29 | Traditional | PDF ↗ |
| K800855 | A,FSC LYOPHILIZED HEMO CONTROL | Helena Laboratories | 1980-04-29 | Traditional | PDF ↗ |
| K791290 | BECKMAN B-4 TEB BUFFER KIT | Beckman Instruments, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K791008 | ECA (SPECIAL) HEME BUFFER | Electrophoresis Corp. of America | 1979-08-03 | Traditional | PDF ↗ |
| K790944 | CITRATE AGAR GEL AND BUFFER SET | Corning Medical & Scientific | 1979-06-28 | Traditional | PDF ↗ |
| K781119 | ECA HEME BUFFER | Electrophoresis Corp. of America | 1978-08-14 | Traditional | PDF ↗ |
| K780807 | HBF-QUIPLATE METHODOLOGY | Helena Laboratories | 1978-06-02 | Traditional | PDF ↗ |
| K780163 | REDI-DISC HEMOGLOBIN GEL TUBE KIT | Miles Laboratories, Inc. | 1978-03-27 | Traditional | PDF ↗ |
| K771649 | HEMOGLOBIN A2 TESTING SYSTEM | Isolab, Inc. | 1977-10-07 | Traditional | PDF ↗ |
Product code JBD · Class II · Hematology. Data: openFDA.