Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
280 devices
Cleared
Jul 07, 1983
TITAN GE/IEPLATE
Chemistry
50d
Cleared
May 13, 1983
HELENA BIOSTRIP A
Chemistry
45d
Cleared
May 05, 1983
HELENA BIOSTRIP PH
Chemistry
37d
Cleared
May 04, 1983
HELENA BIOSTRIP K
Chemistry
36d
Cleared
Apr 28, 1983
HELENA BIOSTRIP P
Chemistry
30d
Cleared
Apr 12, 1983
NEGATIVE URINE CONTROL
Chemistry
27d
Cleared
Apr 12, 1983
TITAN GEL LDH ISO-ENZYME CONTROL
Chemistry
25d
Cleared
Apr 05, 1983
ACTIVAT-PARTIAL THROMBO-PLASTIN
Hematology
64d
Cleared
Apr 05, 1983
LIQUID THROMBOPLASTIN REAGENT
Hematology
63d
Cleared
Mar 24, 1983
TITAN IMMUNO-FIX
Immunology
28d
Cleared
Feb 01, 1983
GLYCO HB QUIK COLUMN PROCEDURE
Hematology
40d
Cleared
Feb 01, 1983
BETA THALQUIK COLUMN #5341
Hematology
40d
Cleared
Dec 28, 1982
FACTOR VIII RELATED ANTIGEN ROCKET EID
Hematology
56d
Cleared
Dec 22, 1982
TITAN GEL LDH ISOENZYME KIT
Chemistry
169d
Cleared
Nov 01, 1982
TITAN GEL CPK ISOENZYME SYSTEM
Chemistry
105d
Cleared
Aug 27, 1982
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO
Chemistry
45d
Cleared
Aug 16, 1982
TITAN GEL SERUM CONTROL
Chemistry
41d
Cleared
Aug 05, 1982
ISOPROPANOL HEMOGLOBIN STABILITY TEST
Hematology
17d
Cleared
Aug 03, 1982
IMMUNO DIAGNOSTICS ASSAY
Chemistry
22d
Cleared
Jul 22, 1982
TITAN GEL CPK/LDH ISOENZYME CONTROL
Chemistry
16d
Cleared
Jun 22, 1982
TITAN GEL HIGH RESOLUTION SERUM PROTEIN
Chemistry
14d
Cleared
Jun 10, 1982
TITANAN GEL SERUM PROTEIN ELECTROPHORES
Chemistry
20d
Cleared
May 12, 1982
FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
Chemistry
50d
Cleared
May 05, 1982
BIOSTRIP G
Chemistry
62d
Cleared
Apr 08, 1982
HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
Hematology
16d
Looking for a specific device from Helena Laboratories? Search by device name or K-number.
Search all Helena Laboratories devices