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510(k) K001043

KAWASUMI LABORATORY BLOOD DRAWING KIT by Kawasumi Laboratories America, Inc. — Product Code KSB

K001043 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories America, Inc. for the device "KAWASUMI LABORATORY BLOOD DRAWING KIT". The FDA issued a decision of Substantially Equivalent on May 19, 2000. The device falls under product code KSB (Set, Transfer (Blood/Plasma)), a Class II device regulated under 21 CFR 864.9875. Kawasumi Laboratories America, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2000
Date Received
March 31, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Transfer (Blood/Plasma)
Device Class
Class II
Regulation Number
864.9875
Review Panel
HE
Submission Type

Other clearances by Kawasumi Laboratories America, Inc.

  • K102890 — K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTEC (October 21, 2010)
  • K030385 — IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACC (April 15, 2003)
  • K001423 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY (July 21, 2000)
  • K001424 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD (July 21, 2000)
  • K001426 — KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER (July 21, 2000)

Other clearances for product code KSB

  • K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) System (September 28, 2018)
  • K820447 — ALPHA PLASMA TRANSFER SET (April 14, 1982)
  • K802940 — SUPER-SPIKE TRANSFER SET (January 15, 1981)
  • K791131 — FLU VEN TR-1 (September 4, 1979)
  • K791130 — FLU-VEN TK-2 (September 4, 1979)

FDA data resources