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510(k) K935983

MICROREADER 4 by Hyperion, Inc. — Product Code JJQ

K935983 is an FDA 510(k) premarket notification submitted by Hyperion, Inc. for the device "MICROREADER 4". The FDA issued a decision of Substantially Equivalent on December 9, 1994. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Hyperion, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1994
Date Received
December 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
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)
  • 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)

Other clearances for product code JJQ

  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (February 4, 1998)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K962113 — ANTHOS PHACTS VERSION MICROPLATE READER (November 5, 1996)
  • K961183 — CBI 7520 READER (August 2, 1996)
  • K962166 — ORIGEN ANALYZER (July 31, 1996)
  • K955077 — ANTHOS 2010 READER (December 4, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)

FDA data resources