Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
280 devices
Cleared
May 29, 1986
CK/LD BUFFER (CAT. NO. 5808)
Chemistry
23d
Cleared
May 06, 1986
PERMACLEAR SOLUTION CAT. NO. 4950
Pathology
14d
Cleared
Oct 22, 1985
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
Chemistry
139d
Cleared
Oct 01, 1985
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
Chemistry
118d
Cleared
Jul 23, 1985
MONITOR IV PLUS
Hematology
91d
Cleared
Dec 05, 1984
COLOSCREEN SELF-TEST
Hematology
100d
Cleared
Nov 09, 1984
TITAN GEL ISO DOT LDH KIT
Chemistry
122d
Cleared
Oct 15, 1984
GLYCO-TEK AFFINITY COLUMN
Hematology
97d
Cleared
Sep 28, 1984
TITAN GEL ISO DOT CPK PROCEDURE
Chemistry
74d
Cleared
Aug 10, 1984
HELENA COLOSCREEN SELF-TEST
Hematology
164d
Cleared
May 02, 1984
FIBRINOGEN ASSAY KIT
Hematology
51d
Cleared
May 01, 1984
BIOSURE
Hematology
67d
Cleared
Apr 05, 1984
RISTOCETIN COFACTOR ASSAY
Hematology
71d
Cleared
Mar 15, 1984
TITAN GEL LIPOPROTEIN ELECTROPHORESIS
Chemistry
154d
Cleared
Feb 27, 1984
TITAN GEL SILVER STAIN SYSTEM
Pathology
112d
Cleared
Jan 18, 1984
AUTO AIC ANALYZER SYSTEM
Chemistry
83d
Cleared
Jan 13, 1984
HELENA BIO STRIP OB
Chemistry
25d
Cleared
Jan 04, 1984
TITANGEL HIGH RESOLUTION CONTROL
Chemistry
79d
Cleared
Dec 16, 1983
FACTOR II DEFICIENT SUBSTRATE PLASMA
Hematology
24d
Cleared
Nov 21, 1983
COLOSCREEN V.P.I.
Immunology
90d
Cleared
Nov 03, 1983
GLYCO-JE,E CPMTRP
Hematology
36d
Cleared
Oct 20, 1983
PLATELET AGGREGATION REAGENT SET
Hematology
90d
Cleared
Sep 12, 1983
BIO SURE STAIN
Chemistry
47d
Cleared
Aug 24, 1983
TITAN GEL GLYCO-HEME SYSTEM
Hematology
57d
Cleared
Aug 08, 1983
BIOCHECK POSITIVE URINE CONTROL
Chemistry
48d
Looking for a specific device from Helena Laboratories? Search by device name or K-number.
Search all Helena Laboratories devices