Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
122 devices
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
Mar 25, 1982
FETAL-TEK CONTROL MATURE
Chemistry
48d
Cleared
Jul 23, 1981
HELENA VMA-SMC CONTROL
Chemistry
22d
Cleared
Jul 01, 1981
HELENA FETAL-TEK 200 MARKER
Chemistry
15d
Cleared
Jun 25, 1981
HELENA FETAL-TEK 200 METHOD
Chemistry
17d
Cleared
Apr 29, 1981
HELENA VMA-SMC COLUMN METHOD
Chemistry
16d
Cleared
Jan 16, 1981
AUTOMATED ELECTROPHORESIS SYSTEM
Chemistry
18d
Cleared
Oct 10, 1980
KEMTROL SERUM CONTROL-NORMAL
Chemistry
37d
Cleared
Oct 10, 1980
KEMTROL SERUM CONTROL ABNORMAL
Chemistry
37d
Cleared
Jul 14, 1980
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
Chemistry
36d
Cleared
Oct 30, 1979
LIPOTROL
Chemistry
21d
Cleared
Oct 30, 1979
LYOPHILIZED HDL CHOLESTEROL CONTROLS
Chemistry
21d
Cleared
Aug 16, 1979
SPECTRO-SUR SET
Chemistry
31d
Cleared
Aug 03, 1979
BUFFERIZER
Chemistry
46d
Cleared
Jun 05, 1979
FETAL MATURITY TEST PROCEDURE
Chemistry
49d
Cleared
Jan 17, 1979
HEMESPEC
Chemistry
42d
Cleared
Mar 28, 1978
HDL CHOLESTEROL METHOD
Chemistry
43d
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