Helena Laboratories
FDA 510(k) medical device clearances.
Clearances by Helena Laboratories — page 3
201–280 of 280- K831603 — TITAN GE/IEPLATE
- K830978 — HELENA BIOSTRIP A
- K830979 — HELENA BIOSTRIP PH
- K830976 — HELENA BIOSTRIP K
- K830977 — HELENA BIOSTRIP P
- K830834 — NEGATIVE URINE CONTROL
- K830872 — TITAN GEL LDH ISO-ENZYME CONTROL
- K830320 — ACTIVAT-PARTIAL THROMBO-PLASTIN
- K830331 — LIQUID THROMBOPLASTIN REAGENT
- K830594 — TITAN IMMUNO-FIX
- K823869 — GLYCO HB QUIK COLUMN PROCEDURE
- K823870 — BETA THALQUIK COLUMN #5341
- K823267 — FACTOR VIII RELATED ANTIGEN ROCKET EID
- K821983 — TITAN GEL LDH ISOENZYME KIT
- K822124 — TITAN GEL CPK ISOENZYME SYSTEM
- K822050 — STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO
- K821982 — TITAN GEL SERUM CONTROL
- K822123 — ISOPROPANOL HEMOGLOBIN STABILITY TEST
- K822026 — IMMUNO DIAGNOSTICS ASSAY
- K821981 — TITAN GEL CPK/LDH ISOENZYME CONTROL
- K821688 — TITAN GEL HIGH RESOLUTION SERUM PROTEIN
- K821517 — TITANAN GEL SERUM PROTEIN ELECTROPHORES
- K820772 — FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
- K820594 — BIOSTRIP G
- K820787 — HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
- K820573 — HELENA HEMOGLOBIN DETECT COLUMN SYS
- K820437 — AVES WRIGHT STAIN
- K820319 — FETAL-TEK CONTROL MATURE
- K813395 — CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
- K812428 — HELENA COLOSCREEN METHOD
- K812226 — HELENA HBF QUIPLATE CONTROL
- K812077 — HELENA SICKLE-THAL QUIK COLUMN METHOD
- K811912 — HELENA VMA-SMC CONTROL
- K811777 — HELENA PLASMINOGEN QUIPLATE PROCEDURE
- K811695 — HELENA FETAL-TEK 200 MARKER
- K811588 — HELENA FETAL-TEK 200 METHOD
- K810992 — HELENA VMA-SMC COLUMN METHOD
- K810475 — HELENA HEMOGLOBIN F CONTROLS
- K803281 — AUTOMATED ELECTROPHORESIS SYSTEM
- K803108 — HELENA HBA2 QUIK COLUMN METHOD
- K803015 — HEMESPEC II
- K803016 — HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
- K802912 — HELENA AT-III QUIPLATE PROCEDURE
- K802232 — AB-TROL COAGULATION CONTROL
- K802108 — KEMTROL SERUM CONTROL-NORMAL
- K802109 — KEMTROL SERUM CONTROL ABNORMAL
- K802233 — GLYCOSYLATED HEMOGLOBIN-SMC COLUMN
- K800857 — HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
- K801932 — HEP-TROL
- K801318 — HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
- K800433 — HELENA COLOCHECK
- K800852 — HEMESPEC CHECK SET
- K800853 — A,SA2 LYOPHILIZED HEMO CONTROL
- K800854 — A,A2 LYOPHILIZED HEMO CONTROL
- K800855 — A,FSC LYOPHILIZED HEMO CONTROL
- K800856 — A,FDA2 LYOPHILIZED HEMO CONTROL
- K800432 — HELENA RISTOCETIN
- K792655 — HELENA COLOSCREEN
- K792656 — HELENA FACTOR XII DEFICIENT
- K792475 — HELENA FACTOR IX DEFICIENT SUBSTRATE
- K792476 — HELENA FACTOR XI DEFICIENT SUBSTRATE
- K792507 — HELENA FACTOR V DEFICIENT SUBSTRATE
- K792508 — HELENA FACTOR X DEFICIENT SUBSTRATE
- K792511 — HELENA FACTOR VII DEFICIENT SUB. PLASMA
- K792336 — HELENA FACTOR II DEFICIENT SUB. PLASMA
- K792310 — NORM-TROL
- K792335 — HELENA FACTOR VIII DEFICIENT SUB. PLASMA
- K792024 — LIPOTROL
- K792025 — LYOPHILIZED HDL CHOLESTEROL CONTROLS
- K791315 — SPECTRO-SUR SET
- K791144 — BUFFERIZER
- K791135 — LYOPHILIZED G-HB QUIK COLUMN CONTROL
- K790798 — FETAL MATURITY TEST PROCEDURE
- K790826 — COAGULATION ARP
- K790646 — HELENA QUIPLATE SYSTEM
- K790583 — QUIK COLUMN METHODOLOGY
- K790046 — G-HB QUIK COLUMN CONTROL
- K782035 — HEMESPEC
- K780807 — HBF-QUIPLATE METHODOLOGY
- K780256 — HDL CHOLESTEROL METHOD
Data sourced from openFDA. This site is unofficial and independent of the FDA.