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510(k) K874244

DYNATECH MR 300 MANUAL MICROELISA by Dynatech Laboratories, Inc. — Product Code JJQ

K874244 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "DYNATECH MR 300 MANUAL MICROELISA". The FDA issued a decision of Substantially Equivalent on November 3, 1987. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Dynatech Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1987
Date Received
October 16, 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 Dynatech Laboratories, Inc.

  • K962265 — MLX MICROTITER PLATE LUMINOMETER (July 25, 1996)
  • K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS) (November 2, 1994)
  • K943701 — MRX MICROPLATE READER (October 20, 1994)
  • K923456 — MICROLITE MICROTITER PLATE LUMINOMETER ML3000 (October 13, 1992)
  • K915896 — MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI (May 4, 1992)
  • K920888 — MICROLITE MICROTITER PLATE LUMINOMETER ML2200 (March 19, 1992)
  • K913590 — MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER (October 25, 1991)
  • K895313 — MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER (October 17, 1989)
  • K894645 — IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (October 17, 1989)
  • K894687 — DYNATECH MR 5000, CATALOG #011-976-0600 (August 31, 1989)

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