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510(k) K850547

MOTILITY INDOLE ORNITHINE AGAR by Hardy Media — Product Code JSE

K850547 is an FDA 510(k) premarket notification submitted by Hardy Media for the device "MOTILITY INDOLE ORNITHINE AGAR". The FDA issued a decision of Substantially Equivalent on March 11, 1985. The device falls under product code JSE (Culture Media, Multiple Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Hardy Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1985
Date Received
February 11, 1985
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 Hardy Media

  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880124 — LOWENSTEIN-JENSEN, W/NACL (March 31, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880133 — MIL MEDIUM (March 31, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880116 — MRVP BROTH (March 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880125 — LOWENSTEIN-JENSEN, SELECTIVE (March 31, 1988)
  • K880123 — LOWENSTEIN-JENSEN SLANT (March 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)

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)
  • K871096 — CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES (April 3, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K860412 — BIOTIS SIM MEDIUM (February 24, 1986)

FDA data resources