JMM · Class I · 21 CFR 862.1400

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

Leading manufacturers include Diagnostic Products Corp., Organon, Inc. and Diagnostic Systems Laboratories, Inc..

21
Total
21
Cleared
134d
Avg days
1977
Since

FDA 510(k) Cleared Column Chromatography & Color Development, Hydroxyproline Devices (Product Code JMM)

21 devices
1–21 of 21
Cleared Jul 24, 2000
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
K993706
Roche Diagnostics Corp.
Chemistry · 265d
Cleared Jan 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS
K983674
Ortho-Clinical Diagnostics, Inc.
Chemistry · 101d
Cleared May 01, 1998
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
K980833
Diagnostic Products Corp.
Chemistry · 58d
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 Mar 28, 1996
ACTIVE CROSSLAPS ELISA
K960171
Diagnostic Systems Laboratories, Inc.
Chemistry · 72d
Cleared Sep 02, 1977
HYPRONOSTICON TM
K770603
Organon, Inc.
Chemistry · 156d

About Product Code JMM - Regulatory Context