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510(k) K925468

Device
JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT
Applicant
J.J. SKINNER, INC.
510(k) number
K925468
Product code
GJE  
Decision
Substantially Equivalent - Kit With Drugs (SEKD)
Decision date
1994-04-11
Date received
1992-10-29
Regulation
862.1675
Classification name
Tray, Blood Collection
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CAROLANN KOTULA-COOK
Address
C/O Medical Device Inspection 55 Northern Blvd., Suite 301 Great Neck NY US 11021 11021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GJE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962596CUSTOMED BLOOD EXTRACTION KITCustomed, Inc.1996-09-27
K780303AUTO ISO-FILTER COLLECTION TUBE CAPBd Becton Dickinson Vacutainer Systems Preanalytic1978-03-30
K771489RTERIAL BLOOD SAMPLING KITBd Becton Dickinson Vacutainer Systems Preanalytic1977-08-22
K771370ICROTAINEO BRAND TUBEBd Becton Dickinson Vacutainer Systems Preanalytic1977-08-03
K761177SODIUM CITRATEBio/Data Corp.1977-01-10
K760086TRAY, BLOOD SAMPLING (PULSATOR II)Concord Laboratories, Inc.1976-07-16

Legacy Summary#

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FDA Review#

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