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510(k) K792481

CULTURE PLATES & TUBED MEDIA by Laboratory Products, Inc. — Product Code JTZ

K792481 is an FDA 510(k) premarket notification submitted by Laboratory Products, Inc. for the device "CULTURE PLATES & TUBED MEDIA". The FDA issued a decision of Substantially Equivalent on December 31, 1979. 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. Laboratory Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1979
Date Received
November 19, 1979
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 Laboratory Products, Inc.

  • K832588 — CIN AGAR (September 12, 1983)
  • K803051 — FLAME PHOTOMETRY REAGENTS (January 9, 1981)
  • K803013 — CHLORIDE/TCO2 ANALYZER REAGENTS (January 2, 1981)
  • K803050 — SPRAY, SYNTHETIC SMEAR (December 30, 1980)
  • K800180 — VARIOUS REAGENTS FOR BLOOD CELL ANALYZER (March 19, 1980)
  • K792482 — CHEMISTRY ANALYZER REAGENTS (January 11, 1980)
  • K792483 — STAINS, COUNTERSTAINS & GEN. PURPOSE (December 18, 1979)

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