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510(k) K992997

Device
OSTEOMARK NTX POC
Applicant
METRIKA, INC.
510(k) number
K992997
Product code
JMM  
Decision
Substantially Equivalent (SESE)
Decision date
1999-11-09
Date received
1999-09-07
Regulation
862.1400
Classification name
Column Chromatography & Color Development, Hydroxyproline
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Erika B Ammirati
Address
510 Oakmead Pkwy. Sunnyvale CA US 94085 94085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JMM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K011052OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USEOstex Intl., Inc.2001-07-30
K993706ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAYRoche Diagnostics Corp.2000-07-24
K990843SERUM CROSSLAPS ONE STEP ELISAOsteometer Biotech A/S1999-07-09
K983457OSTEOMARK NTX SERUM EIAOstex Intl., Inc.1999-02-02
K983674VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSOrtho-Clinical Diagnostics, Inc.1999-01-29
K972788CROSSLAPS ELISADevices and Diagnostics Consulting Group1998-12-22
K981364PYRILINKS-D ASSAY KITMetra Biosystems, Inc.1998-08-13
K980833IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5Diagnostic Products Corp.1998-05-01
K980518OSTEOMARKOstex Intl., Inc.1998-03-06
K974260PYRILINKS-D ASSAY KITMetra Biosystems, Inc.1998-01-26
K972580DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.1997-09-22
K971312IMMULITE PYRILINKS-DDiagnostic Products Corp.1997-05-27
K963251CIBA CORNING ACS;180 DPD ASSAYCiba Corning Diagnostics Corp.1996-10-15
K961562OSTEOMARKOstex Intl., Inc.1996-07-11
K960171ACTIVE CROSSLAPS ELISADiagnostic Systems Laboratories, Inc.1996-03-28

Legacy Summary#

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FDA Review#

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