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510(k) K924361

VACUPLUS TUBES WITH GREEN STOPPERS by Starplex Scientific, Inc. — Product Code JKA

K924361 is an FDA 510(k) premarket notification submitted by Starplex Scientific, Inc. for the device "VACUPLUS TUBES WITH GREEN STOPPERS". The FDA issued a decision of Substantially Equivalent on March 1, 1993. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Starplex Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1993
Date Received
August 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
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)
  • K960997 — STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (April 3, 1996)
  • K944847 — KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM (February 16, 1995)
  • K924364 — VACUPLUS TUBES WITH GREY 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 JKA

  • K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device (June 2, 2026)
  • K260128 — BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes (April 15, 2026)
  • K252378 — BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillar (April 10, 2026)
  • K252506 — BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Bloo (April 10, 2026)
  • K252040 — BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Bloo (March 13, 2026)
  • K251812 — Steripath® Flow™ Blood Collection System (September 25, 2025)
  • K243207 — BD Vacutainer® Eclipse™ Blood Collection Needle (July 3, 2025)
  • K250961 — Blood collection tube holders (June 4, 2025)
  • K244047 — Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (May 23, 2025)
  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)

FDA data resources