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510(k) K863821

MUELLER HINTON AGAR W/4%NACL AND OXACILLIN by Gibco Laboratories Life Technologies, Inc. — Product Code JTZ

K863821 is an FDA 510(k) premarket notification submitted by Gibco Laboratories Life Technologies, Inc. for the device "MUELLER HINTON AGAR W/4%NACL AND OXACILLIN". The FDA issued a decision of Substantially Equivalent on October 9, 1986. 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. Gibco Laboratories Life Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1986
Date Received
September 30, 1986
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 Gibco Laboratories Life Technologies, Inc.

  • K871855 — SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM (May 26, 1987)
  • K871541 — MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 (April 29, 1987)
  • K870134 — MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE (February 4, 1987)
  • K864755 — PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM (January 5, 1987)
  • K864014 — LOMBARD DOWELL AGAR BASE (October 29, 1986)
  • K863820 — DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300 (October 8, 1986)
  • K863289 — CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN (September 3, 1986)
  • K862425 — MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM (July 2, 1986)
  • K861058 — SENSITITRE AUTO ID PLATE, AP70 (May 20, 1986)
  • K861734 — REGAN-LOWE AGAR (May 16, 1986)

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