Panels › Hematology › Product code JBD · Class 2
System, Analysis, Electrophoretic Hemoglobin
Regulation 864.7440
0510(k)s in 12 months (26 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in JBD
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 11 | 1 |
| Corning Medical & Scientific | 3 | 0 |
| Beckman Instruments, Inc. | 2 | 0 |
| Electrophoresis Corp. of America | 2 | 0 |
| Gelman Sciences, Inc. | 2 | 0 |
| Interlab S.R.L. | 2 | 0 |
| Isolab, Inc. | 2 | 0 |
| Miles Laboratories, Inc. | 1 | 0 |
| Morax | 1 | 0 |
| PerkinElmer LAS Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 2006 | K053571 | MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM Interlab S.R.L. | JBD |
| Feb 3, 2004 | K032862 | INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM Interlab S.R.L. | JBD |
| Sep 21, 1999 | K992199 | ACID HEMOGLOBIN KIT Helena Laboratories | JBD |
| Jun 21, 1999 | K991362 | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) Morax | JBD |
| Dec 17, 1998 | K982426 | SPIFE ALKALINE HEMOGLOBIN Helena Laboratories | JBD |
| Aug 16, 1993 | K931503 | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) Helena Laboratories | JBD |
| Jul 6, 1993 | K931465 | REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 Helena Laboratories | JBD |
| May 23, 1990 | K901143 | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) Helena Laboratories | JBD |
| May 4, 1983 | K830804 | LABILE REMOVING HEMOLYZING REAGENT Corning Medical & Scientific | JBD |
| Apr 9, 1982 | K820518 | GELMAN GLYCO-PHORE BUFFER Gelman Sciences, Inc. | JBD |
| Dec 31, 1981 | K813395 | CELLULOSE ACETATE-CITRATE AGAR HEMOGLO Helena Laboratories | JBD |
| Apr 23, 1981 | K810919 | HEMOGLOBIN ELECTROPHORESIS CONTROL Isolab, Inc. | JBD |
| Feb 5, 1981 | K810047 | AUTOPHOR 128 Gelman Sciences, Inc. | JBD |
| Dec 22, 1980 | K802884 | CORNING NORMAL GLYCOSYLATED HEMOGLOBIN Corning Medical & Scientific | JBD |
| Dec 11, 1980 | K802821 | PARAGON HEMOGLOBIN ELECTRO. REAG. KIT Beckman Instruments, Inc. | JBD |
| Apr 29, 1980 | K800856 | A,FDA2 LYOPHILIZED HEMO CONTROL Helena Laboratories | JBD |
| Apr 29, 1980 | K800855 | A,FSC LYOPHILIZED HEMO CONTROL Helena Laboratories | JBD |
| Apr 29, 1980 | K800854 | A,A2 LYOPHILIZED HEMO CONTROL Helena Laboratories | JBD |
| Apr 29, 1980 | K800853 | A,SA2 LYOPHILIZED HEMO CONTROL Helena Laboratories | JBD |
| Aug 3, 1979 | K791290 | BECKMAN B-4 TEB BUFFER KIT Beckman Instruments, Inc. | JBD |
| Aug 3, 1979 | K791008 | ECA (SPECIAL) HEME BUFFER Electrophoresis Corp. of America | JBD |
| Jun 28, 1979 | K790944 | CITRATE AGAR GEL AND BUFFER SET Corning Medical & Scientific | JBD |
| Aug 14, 1978 | K781119 | ECA HEME BUFFER Electrophoresis Corp. of America | JBD |
| Jun 2, 1978 | K780807 | HBF-QUIPLATE METHODOLOGY Helena Laboratories | JBD |
| Mar 27, 1978 | K780163 | REDI-DISC HEMOGLOBIN GEL TUBE KIT Miles Laboratories, Inc. | JBD |
| Oct 7, 1977 | K771649 | HEMOGLOBIN A2 TESTING SYSTEM Isolab, Inc. | JBD |
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