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510(k) K970227

IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER by Dpc Cirrus — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1997
Date Received
January 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

Other clearances by Dpc Cirrus

  • K980855 — IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT (April 21, 1998)

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