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

Hycel, Inc. has 21 FDA 510(k) cleared chemistry devices. Based in Mchenry, US.

Historical record: 21 cleared submissions from 1976 to 1980.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

22 devices
1-22 of 22
Cleared Oct 06, 1980
HYCEL TRIGYCERIDE II TEST
K802422
Chemistry
Cleared Feb 27, 1979
HYCEL M
K790335 · JJF
Chemistry · 6d
Cleared Jan 26, 1979
KETOSTEROID TEST, HYCEL-17
K782116 · CCY
Chemistry · 30d
Cleared Jan 26, 1979
HYCEL LDH-INT TEST
K782176 · CFH
Chemistry · 29d
Cleared Jan 03, 1979
HYCEL COUNTER 333
K782100 · GKL
Hematology · 16d
Cleared Jan 03, 1979
HYCEL COUNTER 222
K782101 · GKL
Hematology · 16d
Cleared Jan 03, 1979
HYCEL COUNTER 211
K782102 · GKL
Hematology · 16d
Cleared Jul 27, 1978
ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
K780946 · JPJ
Hematology · 48d
Cleared Jul 27, 1978
HMA URIC ACID TEST
K781004 · KNK
Chemistry · 41d
Cleared May 03, 1978
LELECTIVE KINETIC SYSTEM-60
K780464 · JJE
Chemistry · 42d
Cleared Apr 05, 1978
DIRECT UREA NITROGEN TEST
K780262 · CDW
Chemistry · 47d
Cleared Jan 30, 1978
17-HYDROXY TEST
K772426 · CDB
Chemistry · 34d
Cleared Aug 22, 1977
ALBUMIN TEST, HMA ALBUMIN TEST
K771259 · CIX
Chemistry · 42d
Cleared Aug 10, 1977
LDH-INT TEST
K771343 · CFH
Chemistry · 21d
Cleared Aug 10, 1977
PLATELET COUNTER & HEMATOCRIT ACCES.
K771353 · GKL
Hematology · 19d
Cleared Jul 21, 1977
CPK-INT TEST
K771154
Chemistry · 23d
Cleared Jul 11, 1977
COUNTER 700 & HC-700 HEMO 0 REF.
K771107 · GKL
Hematology · 21d
Cleared Jul 05, 1977
HEMOTOLOGY PRODU&TS (5 IN ALL)
K770803 · GKK
Chemistry · 64d
Cleared Jun 24, 1977
CREATININE TEST, SUPER SEVENTEEN
K770643 · CGX
Chemistry · 81d
Cleared Jun 01, 1977
TEST, FERROZINE IRON & IRON BINDING
K770748 · JMO
Chemistry · 40d
Cleared Apr 26, 1977
PROPANE, HIGH PURITY, INSTRUMENT GRADE
K770393 · JJO
Chemistry · 57d
Cleared Nov 01, 1976
TEST, REFORMULATED HYCEL HMA CALCIUM
K760468 · CIC
Chemistry · 75d
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