Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

48 results for "Stanbio Laboratory"
1–24 of 48
Search insights Median review: 60d Cleared: 100% Top manufacturer: Stanbio Laboratory Lead specialty: Chemistry
Cleared Jun 10, 2009
STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
K090093 · GKR
Stanbio Laboratory
Hematology · 147d
Cleared Jul 18, 2008
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K081719 · GKR
Stanbio Laboratory
Hematology · 30d
Cleared Jun 30, 2005
CREATININE LIQUICOLOR
K050283 · JFY
Stanbio Laboratory
Chemistry · 143d
Cleared Jun 30, 2005
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
K050266 · JFM
Stanbio Laboratory
Chemistry · 146d
Cleared Mar 14, 2005
STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
K042169 · JJE
Stanbio Laboratory
Chemistry · 215d
Cleared Oct 14, 2004
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
K041155 · DCK
Stanbio Laboratory
Immunology · 164d
Cleared Mar 12, 2004
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL...
K032936 · JIX
Stanbio Laboratory
Chemistry · 172d
Cleared Mar 10, 2004
DIRECT HDL-CHOLESTEROL LIQUID COLOR
K032932 · LBS
Stanbio Laboratory
Chemistry · 170d
Cleared Oct 24, 2003
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482 · GKR
Stanbio Laboratory
Hematology · 73d
Cleared Mar 03, 2003
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
K024182 · CDQ
Precision Systems, Inc.
Chemistry · 74d
Cleared Jun 21, 2002
QUPID PLUS E.R.
K020378 · JHI
Stanbio Laboratory
Chemistry · 136d
Cleared Feb 18, 1998
RAPET CRP
K974429 · DCN
Stanbio Laboratory
Immunology · 86d
Cleared Feb 17, 1998
RAPET RF
K974370 · DHR
Stanbio Laboratory
Immunology · 89d
Cleared Jul 17, 1997
CREATINE KINASE (CK)
K972155 · CGS
Stanbio Laboratory
Chemistry · 42d
Cleared Dec 26, 1996
UREA NITROGEN (BUN) LIQUI-UV
K962418 · CDQ
Stanbio Laboratory
Chemistry · 185d
Cleared Jul 20, 1994
STANBIO ALT/GPT (LUQUI-UV) TEST SET
K941314 · CKA
Stanbio Laboratory
Chemistry · 124d
Cleared Jul 14, 1994
STANBIO Y-GT (LIQUICOLOR) TEST SET
K941315 · JQB
Stanbio Laboratory
Chemistry · 118d
Cleared May 17, 1994
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
K941313 · CJE
Stanbio Laboratory
Chemistry · 60d
Cleared Nov 16, 1993
STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
K932049 · CIT
Stanbio Laboratory
Chemistry · 203d
Cleared Aug 22, 1990
STANBIO CSF/URINE TOTAL PROTEIN TEST SET
K902204 · JIR
Stanbio Laboratory
Chemistry · 98d
Cleared Jul 25, 1989
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010
K893128 · CDL
Stanbio Laboratory
Chemistry · 91d
Cleared Feb 07, 1989
STANBIO MAGNESIUM TEST SET, CAT. NO 0130
K883170 · JGJ
Stanbio Laboratory
Chemistry · 195d
Cleared May 23, 1988
STANBIO SYPHILIS RPR TEST, NO. 1170
K880144 · GMQ
Stanbio Laboratory
Microbiology · 131d
Cleared Mar 24, 1988
STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR
K880467 · JIY
Stanbio Laboratory
Chemistry · 50d