ClearanceBrief
Company ยท US

Harleco

FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1982. Name variants (Inc, Corp, punctuation) are merged.

116510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
CGXAlkaline Picrate, Colorimetry, Creatinine8
CEKBiuret (Colorimetric), Total Protein6
CFRHexokinase, Glucose6
CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes6
CIGDiazo Colorimetry, Bilirubin6
CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus5
CIXBromcresol Green Dye-Binding, Albumin5
CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes5
CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase4
CIJSaccharogenic, Amylase4
CJYAzo Dye, Calcium4
CKANadh Oxidation/Nad Reduction, Alt/Sgpt4
JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase4
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides3
CGAGlucose Oxidase, Glucose3
CITNadh Oxidation/Nad Reduction, Ast/Sgot3
JFJCatalytic Methods, Amylase3
JHWU.V. Method, Cpk Isoenzymes3
LFRGlucose Dehydrogenase, Glucose3
CHHEnzymatic Esterase--Oxidase, Cholesterol2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 12, 1982K820233ULTRAZYME PLUS GAMMA GT(65055-65056)
Harleco
JQB
Dec 31, 1981K813427ULTRACHEM GLUC-DH
Harleco
LFR
Nov 10, 1981K813044ULTRACHEM ALB, ITEM #64970
Harleco
CIX
Nov 10, 1981K813043ULTRACHEM CREA ITEM #64972
Harleco
CGX
Nov 10, 1981K813042ULTRACHEM GLUC-DH SET, ITEM #65048
Harleco
LFR
Nov 10, 1981K813041ULTRAZYME-GT, ITEM #64959 & 65032
Harleco
JQB
Nov 10, 1981K813040ULTRACHEM CA, ITEM #64975
Harleco
CJY
Nov 10, 1981K813039ULTRACHEM E-CHOL, ITEM #65025
Harleco
CHH
Nov 10, 1981K813038ULTRACHEM TP, ITEM #64974
Harleco
CEK
Oct 2, 1981K812594ULTRA ZYME PLUS AMYL #64982 & 65031
Harleco
CIJ
Oct 2, 1981K812593ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
Harleco
CGS
Sep 29, 1981K812596ULTRA ZYME PLUS ALP #64962, 65029 & 30
Harleco
CJE
Sep 29, 1981K812595ULTRA CHEM E-GLU #64976 & 65040
Harleco
CFR
Sep 24, 1981K812592ULTRA ZYME PLUS GOT #64953, 65033 & 34
Harleco
CIT
Sep 24, 1981K812591ULTRA ZYME PLUS GPT, #64956, 65035 & 36
Harleco
CKA
Sep 24, 1981K812590ULTRA ZYME PLUS LDH #64950, 65038 & 39
Harleco
CFJ
Sep 24, 1981K812589ULTRA CHEM E-TRIG #65024
Harleco
CDT
Sep 23, 1981K812500ULTRACHEM URIC ACID ALDH, ITEM #65047
Harleco
CDO
Aug 31, 1981K812258ACR ENZYMATIC GLUCOSE OXIDASE
Harleco
CGA
Jun 25, 1981K811576CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
Harleco
CGS
Jun 25, 1981K811575CARDIOZYME PLUS CK-MB ITEM #65045 (G)
Harleco
JHW
Jun 25, 1981K811574CARDIOZYME PLUS CK-TOTAL ITEM #65046
Harleco
CGS
Jun 25, 1981K811573CARDIOZYME PLUS CK-MB ITEM #65045
Harleco
JHW
May 27, 1981K811202ULTRACHEM GLUC-DH, ITEM NO. 65048
Harleco
LFR
Apr 8, 1981K810684HEMOCOLOR STAIN SET
Harleco
ICC
Mar 31, 1981K810725QUALITROL #65057
Harleco
JJT
Jan 9, 1981K803169CARDIOZYME PLUS CK-TOTAL #65046
Harleco
JHS
Jan 9, 1981K803168CARDIO ZYME PLUS CK-MB #65045
Harleco
JHW
Jun 22, 1978K780829SYSING AND HEMOGLOBIN REAGENT
Harleco
GKR
Jun 14, 1978K780830ISOTONIC BUFFERED SALINE
Harleco
GIF
May 19, 1978K780524ULTRACHEM T-BILI 64971 GILFORD 3500
Harleco
CIG
May 19, 1978K780523ULTRACHEM ENZYMATIC CHOLESTEROL 65025
Harleco
CHH
May 19, 1978K780515ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM
Harleco
CFR
May 19, 1978K780514ULTRACHEM CREATININE 64972, CENTRIFUCHEM
Harleco
CGX
May 19, 1978K780513ULTRA ZYME PLUS AMYL 64982, GILFORD 3500
Harleco
CIJ
Mar 9, 1978K780172TRIGLYCERIDE INSTRUMENT APPLICATION
Harleco
CDT
Mar 9, 1978K780141ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.
Harleco
CIJ
Mar 9, 1978K780100ULTRAZYME PLUS CK-1
Harleco
CGS
Mar 9, 1978K780099ULTRAZYME PLUS GT
Harleco
JPZ
Feb 14, 1978K780101ULTRAZYME PLUS LDH
Harleco
CFJ
Feb 13, 1978K780104ULTRAZYME PLUS HBD
Harleco
JMK
Feb 13, 1978K780103ULTRAZYME PLUS GOT
Harleco
CIT
Feb 13, 1978K780102ULTRAZYME PLUS GPT
Harleco
CKA
Feb 13, 1978K780095ULTRAZYME PLUS ALP
Harleco
CJE
Feb 13, 1978K780094IRON BINDING CAPACITY CHEMISTRY
Harleco
JMO
Feb 13, 1978K780093GLUCOSE REAGENT FOR GLUCOSE ANALYZER
Harleco
CGA
Feb 7, 1978K780092ULTRACHEM ALBUMIN
Harleco
CIX
Feb 1, 1978K780065ULTRACHEM E-GLU, MANUAL DETERM.
Harleco
CFR
Jan 5, 1978K772258CLINICARD CK-II
Harleco
CGS
Dec 6, 1977K772157CREATININE, 64972
Harleco
CGX

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