VACUTAINER BRAND PPT PLASMA PREPARATION TUBE— 510(k) K972075
Substantially EquivalentBecton Dickinson Vacutainer Systems
FDA 510(k) clearance K972075 for VACUTAINER BRAND PPT PLASMA PREPARATION TUBE, Substantially Equivalent on 1998-02-24. Applicant: Becton Dickinson Vacutainer Systems. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Vacutainer Systems
- Product code
- Code PJE
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lake, NJ, US
Recent devices under product code PJE
view allMore clearances from Becton Dickinson Vacutainer Systems
view all- K002456 — MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
- K991702 — MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
- K991088 — VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE
- K991120 — VACUTAINER BRAND CTAD TUBE (MULTIPLE)
- K982541 — VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
Adverse events under product code PJE
product code PJE- Malfunction
- 540
- Total
- 540
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.