Stanbio Laboratory - FDA 510(k) Cleared Devices
47
Total
47
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stanbio Laboratory Chemistry ✕
34 devices
Cleared
Jun 30, 2005
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
Chemistry
146d
Cleared
Jun 30, 2005
CREATININE LIQUICOLOR
Chemistry
143d
Cleared
Mar 14, 2005
STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
Chemistry
215d
Cleared
Mar 12, 2004
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL...
Chemistry
172d
Cleared
Mar 10, 2004
DIRECT HDL-CHOLESTEROL LIQUID COLOR
Chemistry
170d
Cleared
Jun 21, 2002
QUPID PLUS E.R.
Chemistry
136d
Cleared
Jul 17, 1997
CREATINE KINASE (CK)
Chemistry
42d
Cleared
Dec 26, 1996
UREA NITROGEN (BUN) LIQUI-UV
Chemistry
185d
Cleared
Jul 20, 1994
STANBIO ALT/GPT (LUQUI-UV) TEST SET
Chemistry
124d
Cleared
Jul 14, 1994
STANBIO Y-GT (LIQUICOLOR) TEST SET
Chemistry
118d
Cleared
May 17, 1994
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
Chemistry
60d
Cleared
Nov 16, 1993
STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
Chemistry
203d