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510(k) K864201

LAD MODEL 535 LUMINOMETER by Los Alamos Diagnostics — Product Code JJQ

K864201 is an FDA 510(k) premarket notification submitted by Los Alamos Diagnostics for the device "LAD MODEL 535 LUMINOMETER". The FDA issued a decision of Substantially Equivalent on January 13, 1987. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Los Alamos Diagnostics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1987
Date Received
October 27, 1986
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 Los Alamos Diagnostics

  • K896117 — MODIFIED MODEL 535(TM) LUMINOMETER (November 30, 1989)
  • K883385 — RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST (September 7, 1988)
  • K882608 — LAD MODEL 633 LUMINOMETER (August 29, 1988)
  • K881439 — MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM (April 28, 1988)
  • K874262 — LAD MODEL 735 LUMINOMETER (November 27, 1987)
  • K864202 — UTISCREEN(R) BACTERIAL ATP TEST (February 13, 1987)

Other clearances for product code JJQ

  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • 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)

FDA data resources