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510(k) K972075

VACUTAINER BRAND PPT PLASMA PREPARATION TUBE by Becton Dickinson Vacutainer Systems — Product Code PJE

K972075 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vacutainer Systems for the device "VACUTAINER BRAND PPT PLASMA PREPARATION TUBE". The FDA issued a decision of Substantially Equivalent on February 24, 1998. The device falls under product code PJE (Blood/Plasma Collection Device For Dna Testing), a Class II device regulated under 21 CFR 862.1675. Becton Dickinson Vacutainer Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1998
Date Received
June 3, 1997
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 Becton Dickinson Vacutainer Systems

  • K002456 — MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 (November 2, 2000)
  • K991702 — MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, (July 28, 1999)
  • K991088 — VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY- (May 28, 1999)
  • K991120 — VACUTAINER BRAND CTAD TUBE (MULTIPLE) (May 19, 1999)
  • K982541 — VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 (October 28, 1998)
  • K982922 — VACUTAINER BRAND BLOOD COLLECTION SYRINGE (September 22, 1998)
  • K981013 — VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE (June 17, 1998)
  • K980098 — VACUTAINER BRAND PRONTO NEEDLES HOLDER (February 5, 1998)
  • K971449 — VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (June 17, 1997)
  • K960250 — VACUTAINER BRAND PLUS SERUM & SST TUBES (March 29, 1996)

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)
  • K010328 — MULTIPLE (IZON DNA BLOOD COLLECTION KIT) (April 9, 2001)

FDA data resources