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510(k) K022800

VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM by Hyperion, Inc. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2002
Date Received
August 23, 2002
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.

  • K013213 — HYPERION VISIQUANT ANA TEST KIT (June 4, 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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