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510(k) K010328

MULTIPLE (IZON DNA BLOOD COLLECTION KIT) by Izon Business Products, Inc. — Product Code PJE

K010328 is an FDA 510(k) premarket notification submitted by Izon Business Products, Inc. for the device "MULTIPLE (IZON DNA BLOOD COLLECTION KIT)". The FDA issued a decision of Substantially Equivalent on April 9, 2001. The device falls under product code PJE (Blood/Plasma Collection Device For Dna Testing), a Class II device regulated under 21 CFR 862.1675. Izon Business Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2001
Date Received
February 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood/Plasma Collection Device For Dna Testing
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.

Other clearances by Izon Business Products, Inc.

  • K950257 — MULTIPLE (IZON DBS & URINE COLLECTION KIT) (April 14, 1995)
  • K950221 — MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) (March 21, 1995)
  • K950246 — MULTIPLE (IZON URINE COLLECTION KIT) (March 21, 1995)

Other clearances for product code PJE

  • K231469 — PAXgene® Blood DNA Tube (June 21, 2023)
  • K142821 — PAXgene Blood DNA Tube (September 9, 2015)
  • K042927 — VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (April 15, 2005)
  • K031359 — S-MONOVETTE EDTA K2-GEL (September 12, 2003)
  • K014104 — VACUETTE EDTA K2 TUBES (February 1, 2002)
  • K012043 — VACUETTE EDTA K2 GEL TUBES (September 24, 2001)
  • K972075 — VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (February 24, 1998)

FDA data resources