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510(k) K013213

HYPERION VISIQUANT ANA TEST KIT by Hyperion, Inc. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2002
Date Received
September 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Hyperion, Inc.

  • K022800 — VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM (November 25, 2002)
  • K935983 — MICROREADER 4 (December 9, 1994)
  • K913809 — HY-PREP SYSTEM (January 15, 1992)
  • K873138 — MICRO-READER II (September 14, 1987)
  • K864060 — MICRO-READER (November 28, 1986)
  • K855149 — COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER (February 11, 1986)
  • K834071 — LYMPHANGIOGRAPHY SET SPECIAL 30G (January 25, 1984)

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