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510(k) K950104

ELX800 AND EL800 AUTOMATED MICROPLATE READERS by Bio-Tek Instruments, Inc. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
January 11, 1995
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 Bio-Tek Instruments, Inc.

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  • K961862 — MODELS IDA-2 PLUS AND IPT-1 (February 26, 1997)
  • K954391 — MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER (November 17, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)
  • K942923 — CERES 900C & CERES UV900C (February 6, 1995)
  • K944257 — LIONHEART 3 MULTI-PARAMETER SIMULATOR (September 21, 1994)
  • K933519 — INDEX SPO2 SIMULATOR (September 1, 1994)
  • K933548 — ELS 1000 (October 29, 1993)

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)