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510(k) K913809

HY-PREP SYSTEM by Hyperion, Inc. — Product Code JQW

K913809 is an FDA 510(k) premarket notification submitted by Hyperion, Inc. for the device "HY-PREP SYSTEM". The FDA issued a decision of Substantially Equivalent on January 15, 1992. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Hyperion, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1992
Date Received
August 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Pipetting And Diluting, For Clinical Use
Device Class
Class I
Regulation Number
862.2750
Review Panel
CH
Submission Type

Other clearances by Hyperion, Inc.

  • K022800 — VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM (November 25, 2002)
  • K013213 — HYPERION VISIQUANT ANA TEST KIT (June 4, 2002)
  • K935983 — MICROREADER 4 (December 9, 1994)
  • 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)

Other clearances for product code JQW

  • K023955 — BD VIPER INSTRUMENT (June 24, 2003)
  • K973335 — QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (April 30, 1998)
  • K980180 — 2700 SAMPLE MANAGER (February 12, 1998)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K970616 — MINI SAMPLER PROCESSOR (April 21, 1997)
  • K962687 — GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (March 28, 1997)
  • K962859 — MINI SAMPLE PROCESSOR (October 29, 1996)
  • K961896 — MICROLAB 4000, MICROLAB 4200 (August 16, 1996)
  • K961694 — IMPACT (June 21, 1996)
  • K953345 — GENESIS (November 21, 1995)

FDA data resources