Medical Device Manufacturer · US , Mchenry , IL

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

8 submissions · 8 cleared · Since 1984

Recent clearances: VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM, HYPERION VISIQUANT ANA TEST KIT, MICROREADER 4

View 8 510(k) Devices ↓

8

Total

8

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Dec 09, 1994

Chemistry · 360d

Cleared Jan 15, 1992

Chemistry · 142d

Cleared Sep 14, 1987

MICRO-READER II

Chemistry · 35d

Cleared Nov 28, 1986

Chemistry · 39d

Cleared Feb 11, 1986

COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER

Chemistry · 47d