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510(k) K840969

CULTURE MEDIA FOR ANTIMICROBIAL SUSCEP by Chatham Biological — Product Code JTZ

K840969 is an FDA 510(k) premarket notification submitted by Chatham Biological for the device "CULTURE MEDIA FOR ANTIMICROBIAL SUSCEP". The FDA issued a decision of Substantially Equivalent on Apr 13, 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. Chatham Biological has 2 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 13, 1984
Date Received
Mar 6, 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 Chatham Biological

  • K840971 — SELECTIVE CULTURE MEDIUM (Apr 13, 1984)
  • K840970 — CULTURE MEDIUM FOR PATHOGENIC NEISSER (Apr 13, 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 K840969. Report a data issue: hello@regdatalab.com.