Medical Device Manufacturer · US , Mchenry , IL

Hycel, Inc. - FDA 510(k) Cleared Devices

22 submissions · 21 cleared · Since 1976

22

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hycel, Inc. Chemistry ✕

16 devices

1-16 of 16

Cleared Oct 06, 1980

HYCEL TRIGYCERIDE II TEST

Cleared Feb 27, 1979

Chemistry · 6d

Cleared Jan 26, 1979

KETOSTEROID TEST, HYCEL-17

Chemistry · 30d

Cleared Jan 26, 1979

HYCEL LDH-INT TEST

Chemistry · 29d

Cleared Jul 27, 1978

HMA URIC ACID TEST

Chemistry · 41d

Cleared May 03, 1978

LELECTIVE KINETIC SYSTEM-60

Chemistry · 42d

Cleared Apr 05, 1978

DIRECT UREA NITROGEN TEST

Chemistry · 47d

Cleared Jan 30, 1978

17-HYDROXY TEST

Chemistry · 34d

Cleared Aug 22, 1977

ALBUMIN TEST, HMA ALBUMIN TEST

Chemistry · 42d

Cleared Aug 10, 1977

Chemistry · 21d

Cleared Jul 21, 1977

Chemistry · 23d

Cleared Jul 05, 1977

HEMOTOLOGY PRODU&TS (5 IN ALL)

Chemistry · 64d

Cleared Jun 24, 1977

CREATININE TEST, SUPER SEVENTEEN

Chemistry · 81d

Cleared Jun 01, 1977

TEST, FERROZINE IRON & IRON BINDING

Chemistry · 40d

Cleared Apr 26, 1977

PROPANE, HIGH PURITY, INSTRUMENT GRADE

Chemistry · 57d

Cleared Nov 01, 1976

TEST, REFORMULATED HYCEL HMA CALCIUM

Chemistry · 75d