Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
280 devices
Cleared
May 02, 1980
HELENA COLOCHECK
Hematology
65d
Cleared
May 02, 1980
HEMESPEC CHECK SET
Hematology
17d
Cleared
Apr 29, 1980
A,SA2 LYOPHILIZED HEMO CONTROL
Hematology
14d
Cleared
Apr 29, 1980
A,A2 LYOPHILIZED HEMO CONTROL
Hematology
14d
Cleared
Apr 29, 1980
A,FSC LYOPHILIZED HEMO CONTROL
Hematology
14d
Cleared
Apr 29, 1980
A,FDA2 LYOPHILIZED HEMO CONTROL
Hematology
14d
Cleared
Mar 25, 1980
HELENA RISTOCETIN
Hematology
27d
Cleared
Jan 24, 1980
HELENA COLOSCREEN
Hematology
29d
Cleared
Jan 24, 1980
HELENA FACTOR XII DEFICIENT
Hematology
29d
Cleared
Dec 31, 1979
HELENA FACTOR IX DEFICIENT SUBSTRATE
Hematology
28d
Cleared
Dec 31, 1979
HELENA FACTOR XI DEFICIENT SUBSTRATE
Hematology
28d
Cleared
Dec 31, 1979
HELENA FACTOR V DEFICIENT SUBSTRATE
Hematology
27d
Cleared
Dec 31, 1979
HELENA FACTOR X DEFICIENT SUBSTRATE
Hematology
27d
Cleared
Dec 31, 1979
HELENA FACTOR VII DEFICIENT SUB. PLASMA
Hematology
26d
Cleared
Dec 27, 1979
HELENA FACTOR II DEFICIENT SUB. PLASMA
Hematology
38d
Cleared
Dec 04, 1979
NORM-TROL
Hematology
18d
Cleared
Dec 04, 1979
HELENA FACTOR VIII DEFICIENT SUB. PLASMA
Hematology
15d
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 28, 1979
LYOPHILIZED G-HB QUIK COLUMN CONTROL
Hematology
10d
Cleared
Jun 05, 1979
FETAL MATURITY TEST PROCEDURE
Chemistry
49d
Cleared
May 31, 1979
COAGULATION ARP
Hematology
31d
Cleared
May 23, 1979
HELENA QUIPLATE SYSTEM
Immunology
54d
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