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510(k) K853441

Device
FETAL BOVINE SERUM IN TRANSFER CONTAINER
Applicant
NEWPORT BIOSYSTEMS, INC.
510(k) number
K853441
Product code
KJA  
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-26
Date received
1985-08-13
Regulation
864.2240
Classification name
Flask, Tissue Culture
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CULT INNOV
Address
Rod Roberts 150 E. Edinger, Suite C Santa Ana CA US 92705 92705

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KJA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972404VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)Bd Becton Dickinson Vacutainer Systems Preanalytic1997-07-22
K933228KAPTON PEEL POUCHAmerican Fluoroseal Corp.1994-03-30
K885121CELL SCRAPERBd Becton Dickinson Vacutainer Systems Preanalytic1988-12-28
K873889TISSUE CULTURE TUBESNunc, Inc.1987-11-25
K873890TISSUE CULTURE FLASKSNunc, Inc.1987-11-25
K871324DU PONT STERICELL CELL CULTURE SYSTEME.I. Dupont DE Nemours & Co., Inc.1987-04-14
K870865TISSUE CULTURE BAGAmerican Fluoroseal Corp.1987-03-30
K864021TISSUE CULTURE FLASKFenwal Laboratories1986-10-29
K862152TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PRODTravenol Laboratories, S.A.1986-06-16
K861253TISSUE CULTURE FLASK PL 732 PLASTICTravenol Laboratories, S.A.1986-04-11
K852532NEWPORT MEDIA TRANSFER CONTAINERNewport Bio Systems1985-08-22
K823138CELL SCRAPERCorning Costar Corp.1982-11-29

Legacy Summary#

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FDA Review#

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