Atlas FDA

MICROTAINER BRAND TUBE WITH EDTA(K2)

FDA 510(k) clearance K940905 · decided 1994-08-02

Clearance details

K-number
K940905
Device name
MICROTAINER BRAND TUBE WITH EDTA(K2)
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1994-02-24
Decision date
1994-08-02
Days to decision
159 days
Clearance type
Traditional
Product code
JKA
Device class
2
Regulation number
862.1675
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Franklin Lake, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD Vacutainer Microtainer Serum tubes (with or without gel). recall (Z-1603-05)Becton Dickinson & Company2004-10-28
Microtainer Brand Tube with EDTA (K2), Catalog Number 365974. recall (Z-0447-03)Becton Dickinson & Company2003-01-16

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05