JMM · Class I · 21 CFR 862.1400

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

Leading manufacturers include Diagnostic Products Corp., Ciba Corning Diagnostics Corp. and Roche Diagnostics Corp..

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 May 01, 1998
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
K980833
Diagnostic Products Corp.
Chemistry · 58d
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

About Product Code JMM - Regulatory Context