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510(k) K831073

Device
DAC-CEL HCG-MCA KIT RD52
Applicant
WELLCOME DIAGNOSTICS
510(k) number
K831073
Product code
CFL  
Decision
Substantially Equivalent (SESE)
Decision date
1983-09-01
Date received
1983-04-04
Regulation
862.1370
Classification name
Radioimmunoassay, Human Growth Hormone
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CFL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972761SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYSealite Sciences, Inc.1997-09-25
K971353DSL ACTIVE NON-EXTRACTION IGF-I ELISADiagnostic Systems Laboratories, Inc.1997-05-12
K970701DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)Diagnostic Systems Laboratories, Inc.1997-04-02
K962758DSL 9100 IGF-II IRMADiagnostic Systems Laboratories, Inc.1996-08-30
K961678HUMAN GROWTH HORMONE IMMUNOASSAY KITNichols Institute Diagnostics1996-07-08
K961172DSL ACTIVE NON-EXTRACTION IGF-I IRMADiagnostic Systems Laboratories, Inc.1996-04-23
K960551DSL ACTIVE HUMAN GROWTH HORMONE ELISADiagnostic Systems Laboratories, Inc.1996-03-06
K955376IMMULITE HGHDiagnostic Products Corp.1996-02-16
K955390INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAYCorning Nichols Diagnostics1995-12-29
K952505INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)Nichols Institute1995-07-03
K946247IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3Nichols Institute1995-06-23
K951752ACTIVE IGF-I ELISADiagnostic Systems Laboratories, Inc.1995-05-10
K951707DSL ACTIVE IFGBP-3 ELISADiagnostic Systems Laboratories, Inc.1995-05-10
K950510OCTEIA IGF-1 KITImmunodiagnostic Systems , Ltd.1995-04-05
K950228DSL ACTIVE IGFBP-3 IRMA (DSL 6600)Diagnostic Systems Laboratories, Inc.1995-02-22

Legacy Summary#

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FDA Review#

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