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510(k) K850998

URI-KIT by Culture Kits, Inc. — Product Code JSG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1985
Date Received
March 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type

Other clearances by Culture Kits, Inc.

  • K911846 — URI-THREE(TM), MODIFICATION (October 4, 1991)
  • K854672 — CANDI-KIT TM (July 11, 1986)
  • K853488 — STAPH KIT (August 28, 1985)
  • K851225 — URINE DUO (August 13, 1985)
  • K852582 — GONI-KIT (July 12, 1985)
  • K852480 — DERM-KIT (July 9, 1985)
  • K851518 — MUELLER HINTON SENSITIVITY PLATE (April 29, 1985)
  • K850765 — STREP-KIT (April 24, 1985)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881532 — BLOOD AGAR BASE W/LOW PH (April 18, 1988)
  • K881543 — LETHEEN AGAR (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881562 — TRYPTOSE BLOOD AGAR BASE (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881522 — DEXTROSE AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)