FDA 510(k) Applications Submitted by ERIKA B AMMIRATI, RAC, MT (ASCP)
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020234 |
01/23/2002 |
A1CNOW FOR RX HOME USE |
METRIKA, INC. |
| K020235 |
01/23/2002 |
A1CNOW FOR PROFESSIONAL USE |
METRIKA, INC. |
| K140248 |
01/30/2014 |
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K050338 |
02/11/2005 |
MODIFICATION TO: INSTAREAD LITHIUM SYSTEM |
Akers Biosciences, Inc. |
| K130515 |
02/27/2013 |
VIRTUOSO SYSTEM FOR IHC ER (SPI) |
VENTANA MEDICAL SYSTEMS, INC. |
| K130685 |
03/13/2013 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K130870 |
03/29/2013 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K121033 |
04/05/2012 |
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) |
VENTANA MEDICAL SYSTEMS, INC. |
| K131051 |
04/15/2013 |
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K121350 |
05/04/2012 |
VIRTUSO SYSTEM FOR IHC (DO-7) |
VENTANA MEDICAL SYSTEMS, INC. |
| K121516 |
05/22/2012 |
VIRTUOSO SYSTEM FOR IHC HER2 (4B5) |
VENTANA MEDICAL SYSTEMS, INC. |
| K132462 |
08/07/2013 |
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K033847 |
12/11/2003 |
A1CNOW FOR HOME AND PROFESSIONAL USE |
METRIKA, INC. |
| K060850 |
03/28/2006 |
NOD CHEMISTRY CONTROL |
BIORESOURCE TECHNOLOGY, INC. |
| K080896 |
03/31/2008 |
PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST |
PATHWORK DIAGNOSTICS, INC. |
| K981345 |
04/14/1998 |
CHOLESTRON PRO II CHOLESTEROL TEST |
LIFESTREAM DIAGNOSTICS, INC. |
| K991697 |
05/18/1999 |
UNI-GOLD H. PYLORI |
TRINITY BIOTECH, PLC |
| K031579 |
05/20/2003 |
INSTAREAD LITHIUM SYSTEM |
AKERS LABORATORIES, INC. |
| K051321 |
05/20/2005 |
INVIEW |
METRIKA, INC. |
| K031604 |
05/22/2003 |
GLYCOMARK |
TOMEN AMERICA INC. |
| K041600 |
06/14/2004 |
QWIKCHECK-BEADS |
MEDICAL ELECTRONICS SYSTEMS LTD. |
| K982373 |
07/07/1998 |
UNI-GOLD STREP A TEST KIT |
TRINITY BIOTECH, PLC |
| K122143 |
07/19/2012 |
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER |
VENTANA MEDICAL SYSTEMS, INC. |
| K012352 |
07/25/2001 |
SQA, SPERM QUALITY ANALYZER |
MEDICAL ELECTRONIC SYSTEMS, LLC |
| K022661 |
08/09/2002 |
A1CNOW FOR HOME USE |
METRIKA, INC. |
| K992997 |
09/07/1999 |
OSTEOMARK NTX POC |
METRIKA, INC. |
| K013323 |
10/05/2001 |
TCI-31 LIFELONG OVULATION TESTER |
TCI NEW YORK |
| K984530 |
12/21/1998 |
DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE |
METRIKA, INC. |
| K063864 |
12/29/2006 |
QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS |
MEDICAL ELECTRONIC SYSTEMS LTD. |
| K130141 |
01/22/2013 |
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K111753 |
06/22/2011 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
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