MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578— 510(k) K991702
Substantially EquivalentBecton Dickinson Vacutainer Systems
FDA 510(k) clearance K991702 for MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578, Substantially Equivalent on 1999-07-28. Applicant: Becton Dickinson Vacutainer Systems. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Vacutainer Systems
- Product code
- Product code JKA
- 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 JKA
view all- K262242 — Profoject Safe Push Button Blood Collection Sets
- K260857 — Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set
- K252344 — BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)
- K262215 — Profoject Safety Sliding Blood Collection Set
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
More clearances from Becton Dickinson Vacutainer Systems
view all- K002456 — MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
- 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
- K982922 — VACUTAINER BRAND BLOOD COLLECTION SYRINGE
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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 →
Recalls naming K991702
K-number listed on FDA's recall record- Z-0054-2020 — BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
- Z-0055-2020 — BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
- Z-0056-2020 — BD Microtainer SST Part/Catalog No.365967
- Z-0057-2020 — BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
- Z-0058-2020 — BD Microtainer SST- Amber Part/Catalog Number: 365978
- Z-0059-2020 — BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
- Z-0060-2020 — BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
- Z-0061-2020 — BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991702.
Data sourced from openFDA. This site is unofficial and independent of the FDA.