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510(k) K962265

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

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

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  • K894687 — DYNATECH MR 5000, CATALOG #011-976-0600 (August 31, 1989)
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Other clearances for product code JSE

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  • K880116 — MRVP BROTH (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)