Home / 510(k) Clearances / K832243

510(k) K832243

CULTURE MEDIUM FOR ANTIMICROBIAL SUS by Carroll Biological Corp. — Product Code JTZ

K832243 is an FDA 510(k) premarket notification submitted by Carroll Biological Corp. for the device "CULTURE MEDIUM FOR ANTIMICROBIAL SUS". The FDA issued a decision of Substantially Equivalent on September 29, 1983. 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. Carroll Biological Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
July 8, 1983
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 Carroll Biological Corp.

  • K832617 — XYLOSE LYSINE DEOXYCHOLATE (September 12, 1983)
  • K832611 — TRYPTIC SOY AGAR (September 12, 1983)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832618 — BLUE AGAR (September 12, 1983)
  • K832614 — SELENITE BROTH (September 12, 1983)
  • K832612 — CHOCOLATE AGAR & THAYER MARTIN AGAR (September 12, 1983)
  • K832619 — THIOGLYCOLLATE MEDIUM (September 12, 1983)
  • K832613 — MANNITOL SALT AGAR (September 12, 1983)
  • K832616 — MACCONKEY AGAR MEDIA (September 12, 1983)
  • K832615 — SF BROTH (September 12, 1983)

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