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510(k) K980120

DIGENE DML 2000 MICROPLATE LUMINOMETER by Digene Corp. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1998
Date Received
January 13, 1998
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

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  • K981485 — HYBRID CAPTURE II GC-ID (November 29, 1999)
  • K990023 — HYBRID CAPTURE II CT-ID TEST (October 25, 1999)
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  • K971586 — DIGENE CERVICAL BRUSH (September 19, 1997)

Other clearances for product code JJQ

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  • 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)
  • K953005 — BILI-METER (September 28, 1995)