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510(k) K850998

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

K850998 is an FDA 510(k) premarket notification submitted by Culture Kits, Inc. for the device "URI-KIT". The FDA issued a decision of Substantially Equivalent on April 1, 1985. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Culture Kits, Inc. has at least 8 other 510(k) clearances on record.

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)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881558 — TRYPTOSE AGAR (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)

FDA data resources