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510(k) K871415

MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) by Dynatech Laboratories, Inc. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1987
Date Received
April 8, 1987
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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  • K894645 — IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (October 17, 1989)
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  • K894687 — DYNATECH MR 5000, CATALOG #011-976-0600 (August 31, 1989)

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  • 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)