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510(k) K940486

DIGENE DCR-1 LUMINOMETER by Digene Diagnostics, Inc. — Product Code JJQ

K940486 is an FDA 510(k) premarket notification submitted by Digene Diagnostics, Inc. for the device "DIGENE DCR-1 LUMINOMETER". The FDA issued a decision of Substantially Equivalent on April 18, 1995. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1995
Date Received
February 2, 1994
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 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