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510(k) K822131

DERMATOPHYTE TEST MEDIUM by Granite Diagnostics, Inc. — Product Code JSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1982
Date Received
July 19, 1982
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 Granite Diagnostics, Inc.

  • K850970 — BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA (March 29, 1985)
  • K850969 — INHIBITORY MOLD AGAR PLATE (March 29, 1985)
  • K833254 — STREPTOCOCCUS ID TRIPLATE SYSTEM (October 28, 1983)
  • K832365 — TCBS AGAR (September 1, 1983)
  • K831349 — STREPTOCOCUS ID PLATE (May 16, 1983)
  • K830252 — DIPCHEX DIP-SLIDE CULTURE SYS (March 7, 1983)
  • K830251 — CAMPY BLOOD AGAR PLATE (February 28, 1983)
  • K823248 — SCHAEDLER AGARS (December 3, 1982)
  • K823122 — LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM (December 3, 1982)
  • K823139 — SMITH'S MEDIUM (December 3, 1982)

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)
  • 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)