JBD · Class II · 21 CFR 864.7440

FDA Product Code JBD: System, Analysis, Electrophoretic Hemoglobin

Leading manufacturers include Helena Laboratories and Beckman Instruments, Inc..

26
Total
26
Cleared
59d
Avg days
1977
Since

FDA 510(k) Cleared System, Analysis, Electrophoretic Hemoglobin Devices (Product Code JBD)

26 devices
1–24 of 26
Cleared Sep 21, 1999
ACID HEMOGLOBIN KIT
K992199
Helena Laboratories
Hematology · 83d
Cleared Dec 17, 1998
SPIFE ALKALINE HEMOGLOBIN
K982426
Helena Laboratories
Hematology · 157d
Cleared Aug 16, 1993
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
K931503
Helena Laboratories
Hematology · 144d
Cleared Jul 06, 1993
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
K931465
Helena Laboratories
Hematology · 104d
Cleared May 23, 1990
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
K901143
Helena Laboratories
Hematology · 72d
Cleared Dec 31, 1981
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
K813395
Helena Laboratories
Microbiology · 27d
Cleared Dec 11, 1980
PARAGON HEMOGLOBIN ELECTRO. REAG. KIT
K802821
Beckman Instruments, Inc.
Hematology · 31d
Cleared Apr 29, 1980
A,SA2 LYOPHILIZED HEMO CONTROL
K800853
Helena Laboratories
Hematology · 14d
Cleared Apr 29, 1980
A,A2 LYOPHILIZED HEMO CONTROL
K800854
Helena Laboratories
Hematology · 14d
Cleared Apr 29, 1980
A,FSC LYOPHILIZED HEMO CONTROL
K800855
Helena Laboratories
Hematology · 14d
Cleared Apr 29, 1980
A,FDA2 LYOPHILIZED HEMO CONTROL
K800856
Helena Laboratories
Hematology · 14d
Cleared Aug 03, 1979
BECKMAN B-4 TEB BUFFER KIT
K791290
Beckman Instruments, Inc.
Hematology · 24d
Cleared Jun 02, 1978
HBF-QUIPLATE METHODOLOGY
K780807
Helena Laboratories
Hematology · 29d

About Product Code JBD - Regulatory Context