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510(k) K941985

MUELLER HINTON AGAR W/OXACILLIN by Carr-Scarborough Microbiologicals, Inc. — Product Code JTZ

K941985 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "MUELLER HINTON AGAR W/OXACILLIN". The FDA issued a decision of Substantially Equivalent on August 24, 1994. 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. Carr-Scarborough Microbiologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1994
Date Received
April 25, 1994
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 Carr-Scarborough Microbiologicals, Inc.

  • K944554 — BRAIN HEART INFUSION AGAR (October 4, 1994)
  • K905472 — LAP DISCS (February 27, 1991)
  • K905666 — M. CAT. BUTYRATE DISC (February 26, 1991)
  • K891476 — C. ALBICANS SCREEN (April 12, 1989)
  • K882636 — ALN DISCS (February 16, 1989)
  • K882630 — PRO DISCS (February 16, 1989)
  • K863216 — NEIS NZY (September 15, 1986)
  • K860301 — RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE (February 6, 1986)
  • K860302 — PYR DISCS (February 5, 1986)
  • K822930 — CSM CHROMOGENIC B-LACTAMASE DISC (November 1, 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)
  • 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)
  • K871097 — CHOCOLATE MUELLER HINTON AGAR (April 3, 1987)

FDA data resources