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510(k) K841213

ANTIMICROBIAL SUSCEPT-CULTURE MEDIA by Smith River Biologicals — Product Code JTZ

K841213 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "ANTIMICROBIAL SUSCEPT-CULTURE MEDIA". The FDA issued a decision of Substantially Equivalent on Apr 4, 1984. 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. Smith River Biologicals has 11 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 4, 1984
Date Received
Mar 12, 1984
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
510(k)

Other clearances by Smith River Biologicals

  • K923892 — SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA (Jun 21, 1993)
  • K841204 — MULTIPLE BIOCHEMICAL TEST (Apr 17, 1984)
  • K841206 — NON-SELECTIVE & DIFFERENTIAL (Apr 17, 1984)
  • K841207 — NON-SELECTIVE & NON-DIFFERENTIAL (Apr 17, 1984)
  • K841209 — SELECTIVE AND DIFFERENTIAL (Apr 17, 1984)
  • K841211 — SELECTIVE BROTH (Apr 5, 1984)
  • K841208 — PROPAGATING TRANSPORT (Apr 5, 1984)
  • K841210 — SELECTIVE & NON-DIFFERENTIAL (Apr 4, 1984)
  • K841205 — NON PROPAGATING TRANSPORT (Apr 4, 1984)
  • K841212 — SINGLE BIOCHEMICAL TEST (Apr 4, 1984)

Other clearances for product code JTZ

  • K262163 — BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (Sep 14, 2026)
  • K132491 — MUELLER HINTON AGAR (Jun 30, 2014)
  • K963036 — MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD (Oct 7, 1996)
  • K960420 — MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (Apr 4, 1996)
  • K960313 — MUELLER HINTON AGAR WITH 2% NACI (Mar 25, 1996)
  • K945911 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (Apr 4, 1995)
  • K941985 — MUELLER HINTON AGAR W/OXACILLIN (Aug 24, 1994)
  • K882351 — MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 (Jun 28, 1988)
  • K880105 — MULLER HINTON BROTH (Mar 30, 1988)
  • K873268 — MUELLER HINTON MEDIA (Nov 4, 1987)

FDA data resources

Source: FDA 510(k) database entry for K841213. Report a data issue: hello@regdatalab.com.