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510(k) K880107

CAMPY BROTH by Hardy Media — Product Code JSD

K880107 is an FDA 510(k) premarket notification submitted by Hardy Media for the device "CAMPY BROTH". The FDA issued a decision of Substantially Equivalent on March 30, 1988. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. Hardy Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1988
Date Received
January 6, 1988
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

Other clearances by Hardy Media

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

Other clearances for product code JSD

  • K883075 — FASTIDIOUS INOCULUM BROTH (August 15, 1988)
  • K873324 — SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (October 2, 1987)
  • K873218 — BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 (September 23, 1987)
  • K871447 — TODD HEWITT W/CNA (LIM BROTH) (May 13, 1987)
  • K871640 — ALKALINE PEPTONE WATER (May 13, 1987)
  • K870594 — T9802 TSB W/6.5% NACL (March 30, 1987)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K844547 — TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (January 16, 1985)
  • K841836 — SELECTIVE CULTURE MED. TRICHOMONAS (May 14, 1984)
  • K840971 — SELECTIVE CULTURE MEDIUM (April 13, 1984)

FDA data resources