Atlas FDA

JBD

26 FDA 510(k) clearances · Product code

42 daysmedian time to decision
144 days90th percentile
26clearances measured

FDA profile

Official device name
System, Analysis, Electrophoretic Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7440
Medical specialty
Hematology
Flags
Third-party review eligible
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
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 Laboratories1999-09-21
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) (K991362)Morax1999-06-21
SPIFE ALKALINE HEMOGLOBIN (K982426)Helena Laboratories1998-12-17
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K931503)Helena Laboratories1993-08-16
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 (K931465)Helena Laboratories1993-07-06
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K901143)Helena Laboratories1990-05-23
LABILE REMOVING HEMOLYZING REAGENT (K830804)Corning Medical & Scientific1983-05-04
GELMAN GLYCO-PHORE BUFFER (K820518)Gelman Sciences, Inc.1982-04-09
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO (K813395)Helena Laboratories1981-12-31
HEMOGLOBIN ELECTROPHORESIS CONTROL (K810919)Isolab, Inc.1981-04-23
AUTOPHOR 128 (K810047)Gelman Sciences, Inc.1981-02-05
CORNING NORMAL GLYCOSYLATED HEMOGLOBIN (K802884)Corning Medical & Scientific1980-12-22
PARAGON HEMOGLOBIN ELECTRO. REAG. KIT (K802821)Beckman Instruments, Inc.1980-12-11
A,SA2 LYOPHILIZED HEMO CONTROL (K800853)Helena Laboratories1980-04-29
A,FDA2 LYOPHILIZED HEMO CONTROL (K800856)Helena Laboratories1980-04-29
A,A2 LYOPHILIZED HEMO CONTROL (K800854)Helena Laboratories1980-04-29
A,FSC LYOPHILIZED HEMO CONTROL (K800855)Helena Laboratories1980-04-29
BECKMAN B-4 TEB BUFFER KIT (K791290)Beckman Instruments, Inc.1979-08-03
ECA (SPECIAL) HEME BUFFER (K791008)Electrophoresis Corp. of America1979-08-03
CITRATE AGAR GEL AND BUFFER SET (K790944)Corning Medical & Scientific1979-06-28
ECA HEME BUFFER (K781119)Electrophoresis Corp. of America1978-08-14
HBF-QUIPLATE METHODOLOGY (K780807)Helena Laboratories1978-06-02
REDI-DISC HEMOGLOBIN GEL TUBE KIT (K780163)Miles Laboratories, Inc.1978-03-27
HEMOGLOBIN A2 TESTING SYSTEM (K771649)Isolab, Inc.1977-10-07

Track JBD automatically

Every clearance here is in the API, with alerts when new ones post.