Helena Laboratories - FDA 510(k) Cleared Devices
280
Total
280
Cleared
0
Denied
280 devices
Cleared
Apr 01, 1982
HELENA HEMOGLOBIN DETECT COLUMN SYS
Hematology
30d
Cleared
Mar 26, 1982
AVES WRIGHT STAIN
Pathology
37d
Cleared
Mar 25, 1982
FETAL-TEK CONTROL MATURE
Chemistry
48d
Cleared
Dec 31, 1981
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
Microbiology
27d
Cleared
Oct 23, 1981
HELENA COLOSCREEN METHOD
Hematology
59d
Cleared
Sep 01, 1981
HELENA HBF QUIPLATE CONTROL
Hematology
22d
Cleared
Aug 18, 1981
HELENA SICKLE-THAL QUIK COLUMN METHOD
Hematology
27d
Cleared
Jul 23, 1981
HELENA VMA-SMC CONTROL
Chemistry
22d
Cleared
Jul 02, 1981
HELENA PLASMINOGEN QUIPLATE PROCEDURE
Immunology
9d
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
Mar 26, 1981
HELENA HEMOGLOBIN F CONTROLS
Hematology
31d
Cleared
Jan 16, 1981
AUTOMATED ELECTROPHORESIS SYSTEM
Chemistry
18d
Cleared
Jan 09, 1981
HELENA HBA2 QUIK COLUMN METHOD
Hematology
30d
Cleared
Dec 30, 1980
HEMESPEC II
Hematology
32d
Cleared
Dec 30, 1980
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
Hematology
32d
Cleared
Dec 22, 1980
HELENA AT-III QUIPLATE PROCEDURE
Hematology
34d
Cleared
Nov 12, 1980
AB-TROL COAGULATION CONTROL
Hematology
58d
Cleared
Oct 10, 1980
KEMTROL SERUM CONTROL-NORMAL
Chemistry
37d
Cleared
Oct 10, 1980
KEMTROL SERUM CONTROL ABNORMAL
Chemistry
37d
Cleared
Oct 10, 1980
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN
Hematology
25d
Cleared
Sep 26, 1980
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
Hematology
164d
Cleared
Sep 09, 1980
HEP-TROL
Hematology
28d
Cleared
Jul 14, 1980
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
Chemistry
36d
Looking for a specific device from Helena Laboratories? Search by device name or K-number.
Search all Helena Laboratories devices