Medical Device Manufacturer · US , Mchenry , IL

Hycel, Inc.

22 submissions · 21 cleared · Since 1976
22
Total
21
Cleared
0
Denied

Hycel, Inc. — FDA 510(k) Submissions

Hycel, Inc. has submitted 22 FDA 510(k) premarket notifications since 1976, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Cell, Automated (particle Counter), Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase, Porter Silber Hydrazone, 17-hydroxycorticosteroids, Diacetyl-monoxime, Urea Nitrogen, Analyzer, Chemistry (photometric, Discrete), For Clinical Use . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
HYCEL TRIGYCERIDE II TEST
K802422 · Chemistry
Oct 1980
HYCEL M
K790335 · JJF Analyzer, Chemistry,... · Chemistry
Feb 1979 6d
KETOSTEROID TEST, HYCEL-17
K782116 · CCY Zimmerman... · Chemistry
Jan 1979 30d
HYCEL LDH-INT TEST
K782176 · CFH Tetrazolium Int... · Chemistry
Jan 1979 29d
HYCEL COUNTER 333
K782100 · GKL Counter, Cell, Automated... · Hematology
Jan 1979 16d
HYCEL COUNTER 222
K782101 · GKL Counter, Cell, Automated... · Hematology
Jan 1979 16d
HYCEL COUNTER 211
K782102 · GKL Counter, Cell, Automated... · Hematology
Jan 1979 16d
ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
K780946 · JPJ Red-cell Indices, Calculated · Hematology
Jul 1978 48d
HMA URIC ACID TEST
K781004 · KNK Acid, Uric, Uricase... · Chemistry
Jul 1978 41d
LELECTIVE KINETIC SYSTEM-60
K780464 · JJE Analyzer, Chemistry... · Chemistry
May 1978 42d
DIRECT UREA NITROGEN TEST
K780262 · CDW Diacetyl-monoxime, Urea... · Chemistry
Apr 1978 47d
17-HYDROXY TEST
K772426 · CDB Porter Silber Hydrazone,... · Chemistry
Jan 1978 34d
ALBUMIN TEST, HMA ALBUMIN TEST
K771259 · CIX Bromcresol Green... · Chemistry
Aug 1977 42d
LDH-INT TEST
K771343 · CFH Tetrazolium Int... · Chemistry
Aug 1977 21d
PLATELET COUNTER & HEMATOCRIT ACCES.
K771353 · GKL Counter, Cell, Automated... · Hematology
Aug 1977 19d
CPK-INT TEST
K771154 · Chemistry
Jul 1977 23d
COUNTER 700 & HC-700 HEMO 0 REF.
K771107 · GKL Counter, Cell, Automated... · Hematology
Jul 1977 21d
HEMOTOLOGY PRODU&TS (5 IN ALL)
K770803 · GKK Cyanomethemoglobin · Chemistry
Jul 1977 64d
CREATININE TEST, SUPER SEVENTEEN
K770643 · CGX Alkaline Picrate,... · Chemistry
Jun 1977 81d
TEST, FERROZINE IRON & IRON BINDING
K770748 · JMO Ferrozine (colorimetric)... · Chemistry
Jun 1977 40d
PROPANE, HIGH PURITY, INSTRUMENT GRADE
K770393 · JJO Flame Emission Photometer... · Chemistry
Apr 1977 57d
TEST, REFORMULATED HYCEL HMA CALCIUM
K760468 · CIC Cresolphthalein... · Chemistry
Nov 1976 75d
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