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510(k) K962265

MLX MICROTITER PLATE LUMINOMETER by Dynatech Laboratories, Inc. — Product Code JSE

K962265 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "MLX MICROTITER PLATE LUMINOMETER". The FDA issued a decision of Substantially Equivalent on July 25, 1996. The device falls under product code JSE (Culture Media, Multiple Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Dynatech Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1996
Date Received
June 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Multiple Biochemical Test
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Dynatech Laboratories, Inc.

  • 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)
  • K894645 — IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (October 17, 1989)
  • K895313 — MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER (October 17, 1989)
  • K894687 — DYNATECH MR 5000, CATALOG #011-976-0600 (August 31, 1989)
  • K890502 — MICROLITE TUBE LUMINOMETER #011-902-0000 (February 27, 1989)

Other clearances for product code JSE

  • K883995 — X-ACT UREA/TDA (October 12, 1988)
  • K883996 — X-ACT LDC/IND (October 12, 1988)
  • K880116 — MRVP BROTH (March 31, 1988)
  • K880133 — MIL MEDIUM (March 31, 1988)
  • K874537 — KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (November 20, 1987)
  • K871096 — CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES (April 3, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K860415 — BIOTIS SIMMON CITRATE AGAR (February 24, 1986)
  • K860413 — BIOTIS TSI (February 24, 1986)

FDA data resources