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510(k) K871096

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

K871096 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES". The FDA issued a decision of Substantially Equivalent on April 3, 1987. The device falls under product code JSE (Culture Media, Multiple Biochemical Test), a Class I device regulated under 21 CFR 866.2320. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

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

  • K962265 — MLX MICROTITER PLATE LUMINOMETER (July 25, 1996)
  • K883995 — X-ACT UREA/TDA (October 12, 1988)
  • K883996 — X-ACT LDC/IND (October 12, 1988)
  • 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)
  • K860412 — BIOTIS SIM MEDIUM (February 24, 1986)
  • K860415 — BIOTIS SIMMON CITRATE AGAR (February 24, 1986)

FDA data resources