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510(k) K831349

STREPTOCOCUS ID PLATE by Granite Diagnostics, Inc. — Product Code JST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1983
Date Received
April 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Fastidious Organisms
Device Class
Class I
Regulation Number
866.2660
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)
  • 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)
  • K822997 — STREP SELECTIVE AGAR (November 17, 1982)

Other clearances for product code JST

  • K962423 — BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM (August 2, 1996)
  • K854732 — API 50 CHB (CULTURE MEDIA) (March 4, 1986)
  • K841661 — SYNTHETIC BROTH A.O.A.C. (May 11, 1984)
  • K832239 — RIM-HAEMOPHILUS 2 (August 12, 1983)
  • K832051 — RIM-HAEMOPHILUS 1 & 2 (August 12, 1983)