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510(k) K854521

BIOGRAM by Giles Scientific, Inc. — Product Code JTZ

K854521 is an FDA 510(k) premarket notification submitted by Giles Scientific, Inc. for the device "BIOGRAM". The FDA issued a decision of Substantially Equivalent on December 23, 1985. The device falls under product code JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth), a Class II device regulated under 21 CFR 866.1700. Giles Scientific, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1985
Date Received
November 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Device Class
Class II
Regulation Number
866.1700
Review Panel
MI
Submission Type

Other clearances by Giles Scientific, Inc.

  • K944319 — BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM (December 15, 1994)
  • K932122 — BIOMIC VIDEO PLATE READER (March 1, 1994)
  • K843725 — BIOGRAM (May 21, 1985)

Other clearances for product code JTZ

  • K132491 — MUELLER HINTON AGAR (June 30, 2014)
  • K963036 — MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD (October 7, 1996)
  • K960420 — MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (April 4, 1996)
  • K960313 — MUELLER HINTON AGAR WITH 2% NACI (March 25, 1996)
  • K945911 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (April 4, 1995)
  • K941985 — MUELLER HINTON AGAR W/OXACILLIN (August 24, 1994)
  • K882351 — MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 (June 28, 1988)
  • K880105 — MULLER HINTON BROTH (March 30, 1988)
  • K873268 — MUELLER HINTON MEDIA (November 4, 1987)
  • K870649 — MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.) (April 14, 1987)

FDA data resources