Isolab, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ISOLAB'S T4 TEST KIT, NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT, PHENYLALANINE TEST KIT
44
Total
44
Cleared
0
Denied
FDA 510(k) Regulatory Record - Isolab, Inc. Hematology ✕
18 devices
Cleared
Jan 20, 1995
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
Hematology
259d
Cleared
Jan 20, 1995
QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY
Hematology
255d
Cleared
Jan 27, 1994
HEMOCARD, HEMOGLOBIN C ASSAY
Hematology
577d
Cleared
Apr 08, 1993
HEMOCARD HEMOGLOBIN E
Hematology
92d
Cleared
Dec 01, 1992
HEMOCARD(TM) CONTROL
Hematology
104d
Cleared
Nov 17, 1992
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
Hematology
223d
Cleared
Oct 09, 1991
HEMOCARD HEMOGLOBIN S
Hematology
159d
Cleared
Apr 15, 1991
HEMOCARD-AS
Hematology
73d
Cleared
Mar 11, 1991
HEMOCARD CONTROL
Hematology
38d
Cleared
Nov 22, 1988
GHB SAMPLE PAPER
Hematology
277d
Cleared
Sep 09, 1984
SICKLING HEMOGLOBIN CONTROLS, NORMAL
Hematology
102d
Cleared
Apr 04, 1984
SICKLE HB ASSAY
Hematology
16d
Cleared
Feb 04, 1984
RESOLVE-HB
Hematology
31d
Cleared
Jun 25, 1982
QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL
Hematology
109d
Cleared
Jan 16, 1981
ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
Hematology
172d
Cleared
Jul 21, 1980
HEMOHLOBIN A2 CONTROL-LYOPHILIZED
Hematology
35d
Cleared
Jul 17, 1979
SICKLE-CELL F TEST
Hematology
29d
Cleared
Nov 07, 1978
HEMOGLOBIN, TESTING SYSTEM
Hematology
4d