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510(k) K854672

CANDI-KIT TM by Culture Kits, Inc. — Product Code JSI

K854672 is an FDA 510(k) premarket notification submitted by Culture Kits, Inc. for the device "CANDI-KIT TM". The FDA issued a decision of Substantially Equivalent on July 11, 1986. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Culture Kits, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1986
Date Received
November 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

Other clearances by Culture Kits, Inc.

  • K911846 — URI-THREE(TM), MODIFICATION (October 4, 1991)
  • 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)
  • K850998 — URI-KIT (April 1, 1985)

Other clearances for product code JSI

  • K070691 — BBL CHROMAGAR 0157 (November 20, 2007)
  • K974428 — DIPSTREAK (July 30, 1998)
  • K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM (June 9, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K882182 — SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (June 6, 1988)
  • K881572 — XL AGAR BASE (April 18, 1988)
  • K881576 — SELENITE BROTH (April 18, 1988)
  • K881575 — SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)
  • K881555 — TINSDALE AGAR BASE (April 18, 1988)
  • K881577 — MODIFIED SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)

FDA data resources