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510(k) K844547

TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE by bioMerieux, Inc. — Product Code JSD

K844547 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE". The FDA issued a decision of Substantially Equivalent on January 16, 1985. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1985
Date Received
November 21, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective Broth
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

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Other clearances for product code JSD

  • K883075 — FASTIDIOUS INOCULUM BROTH (August 15, 1988)
  • K880107 — CAMPY BROTH (March 30, 1988)
  • K873324 — SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (October 2, 1987)
  • K873218 — BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 (September 23, 1987)
  • K871640 — ALKALINE PEPTONE WATER (May 13, 1987)
  • K871447 — TODD HEWITT W/CNA (LIM BROTH) (May 13, 1987)
  • K870594 — T9802 TSB W/6.5% NACL (March 30, 1987)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K841836 — SELECTIVE CULTURE MED. TRICHOMONAS (May 14, 1984)
  • K840971 — SELECTIVE CULTURE MEDIUM (April 13, 1984)

FDA data resources