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510(k) K980120

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

K980120 is an FDA 510(k) premarket notification submitted by Digene Corp. for the device "DIGENE DML 2000 MICROPLATE LUMINOMETER". The FDA issued a decision of Substantially Equivalent on February 6, 1998. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Digene Corp. has at least 8 other 510(k) clearances on record.

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

Other clearances by Digene Corp.

  • K010891 — MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (September 25, 2001)
  • K010892 — MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (September 24, 2001)
  • K010893 — MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 (September 24, 2001)
  • K981567 — HYBRID CAPTURE II CT/GC TEST (February 29, 2000)
  • K981485 — HYBRID CAPTURE II GC-ID (November 29, 1999)
  • K990023 — HYBRID CAPTURE II CT-ID TEST (October 25, 1999)
  • K974901 — HYBRID CAPTURE SYSTEM CMV DNA ASSAY (September 29, 1998)
  • K971586 — DIGENE CERVICAL BRUSH (September 19, 1997)

Other clearances for product code JJQ

  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • 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)

FDA data resources