Isolab, Inc. - FDA 510(k) Cleared Devices
44
Total
44
Cleared
0
Denied
44 devices
Cleared
May 20, 1986
VISIBLE-HERPES TM TEST SYSTEM
Microbiology
179d
Cleared
Nov 30, 1984
RESOLVE-CSF
Chemistry
114d
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
Mar 24, 1983
QUIK-SEP IGM ISOLATION SYSTEM
Chemistry
27d
Cleared
Dec 03, 1982
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
Chemistry
67d
Cleared
Jun 25, 1982
QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL
Hematology
109d
Cleared
Sep 01, 1981
LIPO-SEP CHOLESTEROL AUDIT SYSTEM
Chemistry
15d
Cleared
May 29, 1981
ALPHA-THAL SCREEN TM CONTROL
Chemistry
49d
Cleared
Apr 23, 1981
HEMOGLOBIN ELECTROPHORESIS CONTROL
Chemistry
17d
Cleared
Jan 16, 1981
ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
Hematology
172d
Cleared
Dec 22, 1980
HDL-CHOLESTEROL CONTROL SERUM
Chemistry
27d
Cleared
Jul 21, 1980
HEMOHLOBIN A2 CONTROL-LYOPHILIZED
Hematology
35d
Cleared
Apr 29, 1980
FAST HEMOGLOBIN CONTROL-LYOPHILIZED
Chemistry
20d
Cleared
Jul 17, 1979
SICKLE-CELL F TEST
Hematology
29d
Cleared
Nov 07, 1978
HEMOGLOBIN, TESTING SYSTEM
Hematology
4d
Cleared
Jul 27, 1978
SCALPEL
General & Plastic Surgery
43d
Cleared
Oct 07, 1977
HEMOGLOBIN A2 TESTING SYSTEM
Chemistry
39d