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510(k) K820846

ANTIMICROBIAL SUSCEP. TEST, MUELLER by Blue Ridge Media Co. — Product Code JTZ

K820846 is an FDA 510(k) premarket notification submitted by Blue Ridge Media Co. for the device "ANTIMICROBIAL SUSCEP. TEST, MUELLER". The FDA issued a decision of Substantially Equivalent on April 16, 1982. 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. Blue Ridge Media Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1982
Date Received
March 26, 1982
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 Blue Ridge Media Co.

  • K820848 — BLUE RIDGE SHEEP BLOOD (April 16, 1982)
  • K820842 — CULTURE MEDIA, NON-SELECTIVE/DIFFER (April 16, 1982)
  • K820840 — CULTURE MEDIA, GENERAL NUTRIENT BROTH (April 16, 1982)
  • K820843 — CULTURE MEDIA SELECTIVE BROTH (April 16, 1982)
  • K820849 — BLUE RIDGE RABBIT BLOOD (April 16, 1982)
  • K820845 — DULTURE MEDIA, SELECTIVE & NON-DIFFER (April 16, 1982)
  • K820844 — CULTURE MEDIA, SELECTIVE & DIFFERENTIAL (April 16, 1982)
  • K820841 — CULTURE MEDIA, MULTIPLE BIOCHEMICAL (April 16, 1982)
  • K820847 — ISOLATION OF PATHOGENIC NEISSERIA (April 16, 1982)
  • K820839 — CULTURE MEDIA, SINGLE BIOCHEM. TEST (April 16, 1982)

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