Atlas FDA

VACUTAINER KIT

FDA 510(k) clearance K914901 · decided 1992-01-08

Clearance details

K-number
K914901
Device name
VACUTAINER KIT
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1991-11-01
Decision date
1992-01-08
Days to decision
68 days
Clearance type
Traditional
Product code
GIM
Device class
2
Regulation number
862.1675
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BD Vacutainer® Citrate Blood Collection Tubes (K240455)Becton, Dickinson and Company2024-10-31
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube (K230493)Becton, Dickinson and Company2023-11-27
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes (K213670)Becton, Dickinson and Company2023-08-25
TransFix/EDTA Vacuum Blood Collection Tubes (K162723)Caltag Medsystems, Ltd.2017-06-22
CYTO-CHEX BCT (K080552)Streck2008-07-31
DS30 HCY BLOOD COLLECTION TUBES (K012152)Drew Scientific , Ltd.2001-09-18
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (K971449)Becton Dickinson Vacutainer Systems1997-06-17
GREINER VACUETTE BLOOD COLLECTION TUBE (K971221)Greiner America, Inc.1997-05-02
LOK-ON NEEDLE DISPOSAL SYSTEM (K951886)Becton Dickinson Vacutainer Systems1995-06-30
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM (K945458)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-02-06
CORVAC PLASTIC BLOOD COLLECTION TUBE (K944814)Sherwood Medical Co.1994-12-19
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER (K940058)Sherwood Medical Co.1994-05-02

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30