Medical Device Manufacturer · US , Walker , MI

Icn Pharmaceuticals, Inc. - FDA 510(k) Cleared Devices

30 submissions · 30 cleared · Since 1977
30
Total
30
Cleared
0
Denied
FDA 510(k) Regulatory Record - Icn Pharmaceuticals, Inc. Chemistry
22 devices
1-22 of 22
Cleared Nov 09, 1995
IMMUCHEM GAL-MW EA
K951329 · JIA
Chemistry · 231d
Cleared May 10, 1977
BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.
K770458 · CIG
Chemistry · 63d
Cleared May 03, 1977
CALCIUM PROCEDURE, TEKPOINT DIRECT
K770449 · CIC
Chemistry · 56d
Cleared May 03, 1977
CHLORIDE PROCEDURE, TEKPOINT DIRECT
K770450 · CHJ
Chemistry · 56d
Cleared May 03, 1977
ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL
K770451 · CIX
Chemistry · 56d
Cleared May 03, 1977
PROTEIN PROCEDURE, TEKPOINT TOTAL
K770452 · CEK
Chemistry · 56d
Cleared May 03, 1977
PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE
K770453 · CIO
Chemistry · 56d
Cleared May 03, 1977
CREATININE PROCEDURE, TEKPOINT
K770454 · CGX
Chemistry · 56d
Cleared May 03, 1977
GLUCOSE PROCEDURE, TEKPOINT DIRECT
K770455 · CGE
Chemistry · 56d
Cleared May 03, 1977
PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT
K770456 · CEO
Chemistry · 56d
Cleared May 03, 1977
CHOLESTEROL PROCEDURE, TEKPOINT TOTAL
K770457 · CGO
Chemistry · 56d
Cleared Apr 29, 1977
URIC ACID PROCEDURE, TEKPOINT DIRECT
K770459 · CDH
Chemistry · 52d
Cleared Apr 05, 1977
CHEMISTRY CONTROL, NORMAL
K770310 · JJY
Chemistry · 48d
Cleared Apr 05, 1977
CHEMISTRY CONTROL, ABNORMAL
K770312 · JJY
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT LDH-L, ENZYME
K770313 · CFJ
Chemistry · 48d
Cleared Apr 05, 1977
BUN, ENZYMATIC
K770315 · CDQ
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT GOT, ENZYME
K770318 · CIT
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT CPK, ENZYME
K770319 · CGS
Chemistry · 48d
Cleared Mar 30, 1977
GLUCOSE REAGENT, ENZYMATIC
K770311 · CFR
Chemistry · 42d
Cleared Mar 30, 1977
REAGENT GPT, ENZYME
K770314 · CKA
Chemistry · 42d
Cleared Mar 30, 1977
ALKALINE PHOSPHATASE ENZYMATIC
K770316 · CJE
Chemistry · 42d
Cleared Mar 30, 1977
GLUCOSE TRINDER, ENZYMATIC
K770317 · CGA
Chemistry · 42d
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