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510(k) K821977

GRAMSTAIN SET by Granite Diagnostics, Inc. — Product Code HYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1982
Date Received
July 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iodine, Grams
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
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 HYI

  • K871286 — GRAM IODINE (April 8, 1987)
  • K842733 — GRAM IODINE (August 10, 1984)
  • K811722 — PARA-PAK (July 15, 1981)
  • K791711 — IMPROVED GRAM STAIN REAGENTS (October 17, 1979)
  • K781584 — GRAM STAIN KIT (October 10, 1978)