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510(k) K871096

CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES by bioMerieux, Inc. — Product Code JSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1987
Date Received
March 18, 1987
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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Other clearances for product code JSE

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  • K880133 — MIL MEDIUM (March 31, 1988)
  • K880116 — MRVP BROTH (March 31, 1988)
  • K874537 — KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (November 20, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K860413 — BIOTIS TSI (February 24, 1986)
  • K860415 — BIOTIS SIMMON CITRATE AGAR (February 24, 1986)