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510(k) K870231

KULTSURE by Ncs Diagnostics, Inc. — Product Code LIO

K870231 is an FDA 510(k) premarket notification submitted by Ncs Diagnostics, Inc. for the device "KULTSURE". The FDA issued a decision of Substantially Equivalent on February 4, 1987. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Ncs Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1987
Date Received
January 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

Other clearances by Ncs Diagnostics, Inc.

  • K943499 — KULTSURE STARSWAB(M240), MODIFICATION (November 30, 1994)
  • K943498 — KULTSURE STARSWAB (M210), MODIFICATION (November 30, 1994)
  • K882811 — STREPSLIDE (October 25, 1988)
  • K881209 — ASO SLIDE TEST (April 12, 1988)
  • K874019 — STAPHSLIDE (October 28, 1987)
  • K871404 — KULTSURE (April 21, 1987)
  • K860178 — KULTSURE (CULTURE TRANSPORT) (April 4, 1986)
  • K860655 — KULTSURE (CATALOGUE NO. M200) (March 6, 1986)
  • K860656 — KULTSURE (CATALOGUE NO. M210) (March 4, 1986)
  • K860657 — KULTSURE (CATALOGUE NO. M240) (March 4, 1986)

Other clearances for product code LIO

  • K222613 — ARX Liquid Amies Collection & Transport System (March 27, 2024)
  • K131630 — PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (October 21, 2013)
  • K120846 — TRANSPORT CULTURE MEDIUM DEVICE (June 8, 2012)
  • K103805 — MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION (January 25, 2011)
  • K082472 — VIROCULT, MODEL MW950 (December 30, 2008)
  • K070062 — COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL (July 30, 2007)
  • K013711 — BACTI-SWAB DRY (November 26, 2001)
  • K003761 — NAT - NUCLEIC ACID TRANSPORT (May 31, 2001)
  • K983119 — ENTERO-TEST HP, MODEL #102-01 (March 15, 1999)
  • K981391 — PAR-ONE (July 14, 1998)

FDA data resources