Medical Device Manufacturer · US , Rome , NY

Prisma Systems - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1994
27
Total
27
Cleared
0
Denied

FDA 510(k) Regulatory Record - Prisma Systems Chemistry

24 devices
1-24 of 24
Cleared Mar 03, 1995
CK QVET
K950177 · CGS
Chemistry · 45d
Cleared Dec 29, 1994
GLUCOSE QVET
K942963 · CFR
Chemistry · 189d
Cleared Dec 29, 1994
LACTATE DEHYDROGENASE QVET
K942964 · CFJ
Chemistry · 189d
Cleared Dec 29, 1994
ALKALINE PHOSPHATASE (ALKP) QVET
K942997 · CJE
Chemistry · 189d
Cleared Dec 29, 1994
MAGNESIUM QVET
K943001 · JGJ
Chemistry · 189d
Cleared Dec 29, 1994
BUN QVET
K943042 · CDN
Chemistry · 185d
Cleared Dec 13, 1994
ALBUMIN QVET
K943000 · CIX
Chemistry · 173d
Cleared Dec 13, 1994
AST QVET
K944102 · CIT
Chemistry · 112d
Cleared Dec 09, 1994
PHOSPHATE QVET
K942960 · CEO
Chemistry · 169d
Cleared Dec 09, 1994
AMYLASE QVET
K942961 · JFJ
Chemistry · 169d
Cleared Dec 09, 1994
CALCIUM QVET
K943003 · CJJ
Chemistry · 169d
Cleared Dec 09, 1994
TOTAL PROTEIN QVET
K943004 · CEK
Chemistry · 169d
Cleared Dec 09, 1994
POTASSIUM QVET
K943026 · CEJ
Chemistry · 165d
Cleared Dec 07, 1994
GGT QVET
K942962 · JQB
Chemistry · 167d
Cleared Dec 07, 1994
CHLORIDE QVET
K943006 · CHJ
Chemistry · 167d
Cleared Dec 07, 1994
HDL QVET
K943028 · LBS
Chemistry · 163d
Cleared Dec 02, 1994
BILIRUBIN(TOTAL) QVET
K942999 · CIG
Chemistry · 162d
Cleared Dec 02, 1994
URIC ACID QVET
K943002 · KNK
Chemistry · 162d
Cleared Dec 02, 1994
IRON QVET
K943029 · JIY
Chemistry · 158d
Cleared Nov 30, 1994
PROCHEM CHEMISTRY ANALYZER
K944028 · JJE
Chemistry · 105d
Cleared Nov 22, 1994
BILIRUBIN (DIRECT) QVET
K942949 · CIG
Chemistry · 152d
Cleared Nov 22, 1994
TRIGLYCERODES QVET
K942998 · CDT
Chemistry · 152d
Cleared Nov 22, 1994
CREATININE QVET
K943005 · CGX
Chemistry · 152d
Cleared Nov 22, 1994
ALT QVET
K944080 · CKA
Chemistry · 92d
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