FDA 510(k) Applications Submitted by JAMES W HAYNES
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100005 |
01/04/2010 |
BD PEN NEEDLE |
BECTON, DICKINSON AND CO. |
| K141384 |
05/27/2014 |
WHISPERJECT AUTOINJECTOR |
SCANDINAVIAN HEALTH LIMITED |
| K002456 |
08/10/2000 |
MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 |
BECTON DICKINSON VACUTAINER SYSTEMS |
| K124026 |
12/28/2012 |
LOBSTER AUTO-INJECTOR |
SCANDINAVIAN HEALTH LIMITED |
| K060007 |
01/03/2006 |
BD AUTOSHIELD PEN NEEDLE |
BECTON DICKINSON & CO. |
| K980996 |
03/17/1998 |
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K991120 |
04/02/1999 |
VACUTAINER BRAND CTAD TUBE (MULTIPLE) |
BECTON DICKINSON VACUTAINER SYSTEMS |
| K991551 |
05/03/1999 |
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K971902 |
05/23/1997 |
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K972214 |
06/12/1997 |
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K972721 |
07/21/1997 |
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K972891 |
08/05/1997 |
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K973075 |
08/18/1997 |
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K973369 |
09/08/1997 |
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K974695 |
12/16/1997 |
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K974840 |
12/24/1997 |
ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
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