FDA 510(k) Searchable Database - Search 175,000+ Clearances

Cleared Apr 11, 2003

WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN...

K030320 · JIS

Wako Chemicals USA, Inc.

Chemistry · 71d

Cleared Apr 10, 2003

BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR

K030804 · JIX

Bayer Healthcare, LLC

Chemistry · 28d

Cleared Apr 09, 2003

BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL

K030801 · JJY

Bayer Healthcare, LLC

Chemistry · 27d

Cleared Apr 09, 2003

MID STREAM PREGNANCY TEST

K023037 · LCX

Advanced Diagnostics, Inc.

Chemistry · 209d

Cleared Apr 01, 2003

HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103

K021622 · MQM

Hill-Rom Air-Shields

Chemistry · 320d

Cleared Mar 31, 2003

G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE

K024006 · JBF

Pointe Scientific, Inc.,

Chemistry · 117d

Cleared Mar 31, 2003

VBL SERUM TROPONIN I TEST, MODEL 1001

K023505 · MMI

Vancouver Biotech , Ltd.

Chemistry · 164d

Cleared Mar 28, 2003

EXPRESS BLOOD GLUCOSE MONITORING SYSTEM

K024347 · CGA

Hypoguard USA, Inc.

Chemistry · 88d

Cleared Mar 26, 2003

CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL

K030705 · JJY

Cliniqa Corporation

Chemistry · 20d

Cleared Mar 21, 2003

CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL

K030768 · JJT

Cliniqa Corporation

Chemistry · 10d

Cleared Mar 19, 2003

ATAC CALIBRATOR

K030621 · JIX

Elan Diagnostics

Chemistry · 20d

Cleared Mar 19, 2003

WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553

K030482 · JJY

Wiener Laboratories

Chemistry · 34d

Cleared Mar 19, 2003

SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

K030057 · MMI

Spectral Diagnostics, Inc.

Chemistry · 71d

Cleared Mar 18, 2003

WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006

K024305 · JIX

Wiener Laboratories Saic

Chemistry · 84d

Cleared Mar 18, 2003

URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K022096 · KNK

Bayer Diagnostics Corp.

Chemistry · 264d

Cleared Mar 17, 2003

SAS RSV CONTROL KIT

K030628 · JJX

Sa Scientific, Inc.

Chemistry · 18d

Cleared Mar 14, 2003

MAS LIPID LEVEL 1 AND 2

K030679 · JJY

Medical Analysis Systems, Inc.

Chemistry · 10d

Cleared Mar 13, 2003

LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES...

K030566 · JJY

Cliniqa Corporation

Chemistry · 17d

Cleared Mar 13, 2003

ATAC CALCIUM REAGENT AND ATAC CALIBRATOR

K023105 · CIC

Elan Diagnostics

Chemistry · 176d

Cleared Mar 10, 2003

ATAC PAK MAGNESIUM REAGENT

K030010 · JGJ

Elan Diagnostics

Chemistry · 67d

Cleared Mar 07, 2003

ATAC PAK PHOSPHORUS REAGENT

K030015 · CEO

Elan Diagnostics

Chemistry · 64d

Cleared Mar 07, 2003

ATAC PAK ALBUMIN REAGENT

K030006 · CIX

Elan Diagnostics

Chemistry · 64d

Cleared Mar 06, 2003

URS-1B (BLOOD TEST)

K023297 · JIO

Teco Diagnostics

Chemistry · 155d

Cleared Mar 03, 2003

BAYER LIGAND PLUS 1, 2, 3 CONTROLS

K030452 · JJY

Bayer Diagnostics Corp.

Chemistry · 20d