Cleared Traditional

DIGENE DML 2000 MICROPLATE LUMINOMETER

K980120 · Digene Corp. · Chemistry
Feb 1998
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K980120 is an FDA 510(k) clearance for the DIGENE DML 2000 MICROPLATE LUMINOMETER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Digene Corp. (Beltsville, US). The FDA issued a Cleared decision on February 6, 1998, 24 days after receiving the submission on January 13, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K980120 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1998
Decision Date February 06, 1998
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

Similar Devices — JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 257
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
K013371 · Otsuka Pharmaceutical Co., Ltd. · Dec 2001
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
K973938 · Sfri, Inc. · Feb 1998
STAT TRACKS
K974762 · Awareness Technology, Inc. · Jan 1998
ANTHOS PHACTS VERSION MICROPLATE READER
K962113 · Columbia Bioscience, Inc. · Nov 1996
CBI 7520 READER
K961183 · Columbia Bioscience, Inc. · Aug 1996
ORIGEN ANALYZER
K962166 · Igen, Inc. · Jul 1996