FDA Product Code JMM: Column Chromatography & Color Development, Hydroxyproline

Cleared Jul 30, 2001

OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE

K011052

Ostex Intl., Inc.

Chemistry · 115d

Cleared Jul 24, 2000

ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY

K993706

Roche Diagnostics Corp.

Chemistry · 265d

Cleared Nov 09, 1999

OSTEOMARK NTX POC

K992997

Metrika, Inc.

Chemistry · 63d

Cleared Jul 09, 1999

SERUM CROSSLAPS ONE STEP ELISA

K990843

Osteometer Biotech A/S

Chemistry · 116d

Cleared Feb 02, 1999

OSTEOMARK NTX SERUM EIA

K983457

Ostex Intl., Inc.

Chemistry · 125d

Cleared Jan 29, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS

K983674

Ortho-Clinical Diagnostics, Inc.

Chemistry · 101d

Cleared Dec 22, 1998

CROSSLAPS ELISA

K972788

Devices and Diagnostics Consulting Group

Chemistry · 512d

Cleared Aug 13, 1998

PYRILINKS-D ASSAY KIT

K981364

Metra Biosystems, Inc.

Chemistry · 120d

Cleared May 01, 1998

IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5

K980833

Diagnostic Products Corp.

Chemistry · 58d

Cleared Mar 06, 1998

OSTEOMARK

K980518

Ostex Intl., Inc.

Chemistry · 49d

Cleared Jan 26, 1998

PYRILINKS-D ASSAY KIT

K974260

Metra Biosystems, Inc.

Chemistry · 74d

Cleared Sep 22, 1997

DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K972580

Bayer Corp.

Chemistry · 74d

Cleared May 27, 1997

IMMULITE PYRILINKS-D

K971312

Diagnostic Products Corp.

Chemistry · 48d

Cleared Oct 15, 1996

CIBA CORNING ACS

K963251

Ciba Corning Diagnostics Corp.

Chemistry · 57d

Cleared Jul 11, 1996

OSTEOMARK

K961562

Ostex Intl., Inc.

Chemistry · 80d

Cleared Mar 28, 1996

ACTIVE CROSSLAPS ELISA

K960171

Diagnostic Systems Laboratories, Inc.

Chemistry · 72d

Cleared Sep 02, 1977

HYPRONOSTICON TM

K770603

Organon, Inc.

Chemistry · 156d