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510(k) K960997

STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM by Starplex Scientific, Inc. — Product Code LIO

K960997 is an FDA 510(k) premarket notification submitted by Starplex Scientific, Inc. for the device "STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 3, 1996. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Starplex Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1996
Date Received
March 12, 1996
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 Starplex Scientific, Inc.

  • K032246 — MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (August 13, 2003)
  • K022388 — STARTOX DRUG OF ABUSE SCREENING TEST (4) (February 27, 2003)
  • K021006 — STARTOX DRUG OF ABUSE SCREENING TEST (June 10, 2002)
  • K962843 — MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (September 18, 1996)
  • K944847 — KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM (February 16, 1995)
  • K924364 — VACUPLUS TUBES WITH GREY STOPPERS (March 1, 1993)
  • K924361 — VACUPLUS TUBES WITH GREEN STOPPERS (March 1, 1993)
  • K924362 — VACUPLUS TUBES WITH LAVANDER STOPPERS (March 1, 1993)
  • K924363 — VACUPLUS(R) STAR-SEP(TM) (February 8, 1993)
  • K924365 — VACUPLUS TUBES WITH BRICK RED STOPPERS (December 28, 1992)

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