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510(k) K951848

Device
AIA-PACK CPR ASSAY
Applicant
TOSOH MEDICS, INC.
510(k) number
K951848
Product code
JKD  
Decision
Substantially Equivalent (SESE)
Decision date
1996-02-13
Date received
1995-04-21
Regulation
862.1135
Classification name
Radioimmunoassay, C-peptides Of Proinsulin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LORI ROBINSON
Address
373 D Vintage Park Dr. Foster City CA US 94404 94404

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JKD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943767IMMULITE C-PEPTIDEDiagnostic Products Corp.1995-03-23
K896420DSL C-PEPTIDE RIA (DSL #7000)Diagnostic Systems Laboratories, Inc.1990-05-24
K854066DOUBLE ANTIBODY C-PEPTIDE RIA KITDiagnostic Products Corp.1985-11-12
K842267C-PEP-RIA-100Institut National Des Radioelements1984-09-06
K833396C-PEPTIDE RADIOIMMUNOASSAY TEST KITSerono Diagnostics, Inc.1984-04-13
K820666HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.Immuno Nuclear Corp.1982-07-13
K812689RIA QUANT C-PEPTIDE KITMallinckrodt Critical Care1981-10-06
K812288HUMAN C-PEPTIDE REAGENTSImmunex Radiochemical Diagnostics1981-08-31
K810718C-PEPTICE REAGENTSCalbiochem-Behring Corp.1981-03-31

Legacy Summary#

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FDA Review#

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