Home / 510(k) Clearances / K841138

510(k) K841138

MUELLER HINTON AGAR W/BLOOD & COFACTOR by Anaerobe Systems — Product Code JTZ

K841138 is an FDA 510(k) premarket notification submitted by Anaerobe Systems for the device "MUELLER HINTON AGAR W/BLOOD & COFACTOR". 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. Anaerobe Systems has 51 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 4, 1984
Date Received
Mar 16, 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 Anaerobe Systems

  • K844383 — KANAMYCIN 1000 MCG DIFFERENTIAL DISK (Jan 4, 1985)
  • K844380 — BILE DIFFERENTIAL DISK (Jan 4, 1985)
  • K844381 — COLISTIN 10 MCG. DIFFERENTIAL DISK (Jan 4, 1985)
  • K844382 — VANCOMYCIN 5MCG DIFFERENTIAL DISK (Jan 4, 1985)
  • K841303 — CAMPYLOBACTER THIOGLYCOLLATE MED (Apr 17, 1984)
  • K841218 — CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR (Apr 5, 1984)
  • K841142 — LEVINE EOSIN METHYLENE BLUE AGAR (Apr 5, 1984)
  • K841222 — BACTEROIDES BILE ESCULIN GAR (Apr 4, 1984)
  • K841221 — BRAIN HEART INFUSION BROTH (Apr 4, 1984)
  • K841220 — ANAEROBIC TRANSPORT MEDIUM (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 K841138. Report a data issue: hello@regdatalab.com.