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510(k) K811370

Device
NATAL-TEC HPL
Applicant
ARMKEL, LLC.
510(k) number
K811370
Product code
JMF  
Decision
Substantially Equivalent (SESE)
Decision date
1981-05-29
Date received
1981-05-14
Regulation
862.1585
Classification name
Radioimmunoassay, Human Placental Lactogen
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
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 JMF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944933IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)Diagnostic Products Corp.1995-03-10
K840588AMERLEX HUMAN PLACENTAL LACTOGENAmersham Corp.1984-04-04
K823292IMMOPHASE TM HPL RADIOIMMUNOASSAYCorning Medical & Scientific1982-12-28
K823201HUMAN PLACENTAL LACTOGEN KITDiagnostic Products Corp.1982-11-29
K802454GESTE FOLLOW KIT DETERM. OF HPLSyn-Kit, Inc.1980-11-12
K790919HPL RIA KITTechnia Diagnostics , Ltd.1979-06-28
K782099RIA TEST, NORDICALB HPLNordiclab Intl.1979-01-10
K771656PROLACTIN RIA DIAG. KITAbbott Laboratories1977-09-22
K770659RIALYZE HPL (RIA)Miles Laboratories, Inc.1977-05-20

Legacy Summary#

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FDA Review#

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