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510(k) K821145

Device
I-DHEA-SULFATE RIA KIT 125
Applicant
NUCLEAR MEDICAL SYSTEMS, INC.
510(k) number
K821145
Product code
JKC  
Decision
Substantially Equivalent (SESE)
Decision date
1982-05-14
Date received
1982-04-21
Regulation
862.1245
Classification name
Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JKC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040181ACCESS DHEA-S REAGENT ASSAYBeckman Coulter, Inc.2004-03-24
K003174ELECSYS DHEA-SRoche Diagnostics Corp.2001-01-17
K973897DHEA-SKmi Diagnostics, Inc.1997-11-13
K962895DSL DHEA-S-7Diagnostic Systems Laboratories, Inc.1996-09-10
K955114DSL AACTIVE DHEA EIA KITDiagnostic Systems Laboratories, Inc.1996-02-23
K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYNichols Institute1995-05-15
K942051SR1 DHEA-S ENZYME IMMUNOASSAYSerono Diagnostics, Inc.1994-07-13
K935014ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)Diagnostic Systems Laboratories, Inc.1994-05-09
K935806IMMULITE DHEA-S04Diagnostic Products Corp.1994-04-26
K935469SYNELISA DHEA-SULFATEElias U.S.A., Inc.1994-03-22
K931601CHEMILUMINESCENCE DHEA-S IMMUNOASSAYNichols Institute1993-07-27
K903616DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)Diagnostic Systems Laboratories, Inc.1990-09-10
K891478DSL 7900 ACTIVE DHEA-S (DSL #7900)Diagnostic Systems Laboratories, Inc.1989-04-26
K872879DHEA-S RIA KITEndocrine Associates, Inc.1987-10-23
K853867PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAYPantex, Div. Bio-Analysis, Inc.1985-10-04

Legacy Summary#

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FDA Review#

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