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510(k) K873583

AUTO-EIA by Labsystems, Inc. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1987
Date Received
September 3, 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

Other clearances by Labsystems, Inc.

  • K923365 — TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM (March 24, 1993)
  • K896474 — RESUBMITTED FECATWIN SENSITIVE - FECA-EIA (January 25, 1990)
  • K890154 — MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA (February 7, 1989)
  • K890091 — MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT (February 3, 1989)
  • K881243 — RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 (April 4, 1988)
  • K873780 — MODIFICATION RUBELLA IGM EIA TEST KIT (October 15, 1987)
  • K872252 — MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT (July 1, 1987)
  • K862705 — CYTOMEGALOVIRUS IGG EIA TEST KIT (October 1, 1986)
  • K862431 — RUBELLA IGM EIA TEST KIT (August 8, 1986)
  • K862216 — TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) (June 30, 1986)

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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)