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JMM — Column Chromatography & Color Development, Hydroxyproline Class I

FDA Device Classification

Classification Details

Product Code
JMM
Device Class
Class I
Regulation Number
862.1400
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K011052ostex intlOSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USEJuly 30, 2001
K993706roche diagnosticsELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAYJuly 24, 2000
K992997metrikaOSTEOMARK NTX POCNovember 9, 1999
K990843osteometer biotechSERUM CROSSLAPS ONE STEP ELISAJuly 9, 1999
K983457ostex intlOSTEOMARK NTX SERUM EIAFebruary 2, 1999
K983674ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLJanuary 29, 1999
K972788devices and diagnostics consulting groupCROSSLAPS ELISADecember 22, 1998
K981364metra biosystemsPYRILINKS-D ASSAY KITAugust 13, 1998
K980833diagnostic productsIMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5May 1, 1998
K980518ostex intlOSTEOMARKMarch 6, 1998
K974260metra biosystemsPYRILINKS-D ASSAY KITJanuary 26, 1998
K972580bayerDEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMSeptember 22, 1997
K971312diagnostic productsIMMULITE PYRILINKS-DMay 27, 1997
K963251ciba corning diagnosticsCIBA CORNING ACS;180 DPD ASSAYOctober 15, 1996
K961562ostex intlOSTEOMARKJuly 11, 1996
K960171diagnostic systems laboratoriesACTIVE CROSSLAPS ELISAMarch 28, 1996
K952320metra biosystemsPYRILINKS-D ASSAY KITDecember 29, 1995
K952026metra biosystemsPYRILINKS POLYCLONAL ASSAY KITNovember 3, 1995
K952506metra biosystemsPYRILINKS ASSAY KITNovember 3, 1995
K945946ostex intlOSTEOMARK(R)May 8, 1995