FDA 510(k) Applications Submitted by P. ARMSTRONG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000375 |
02/07/2000 |
RANDOX CALCIUM |
RANDOX LABORATORIES, LTD. |
| K040350 |
02/12/2004 |
RANDOX AMPHETAMINE CLASS ASSAY |
RANDOX LABORATORIES, LTD. |
| K040351 |
02/12/2004 |
RANDOX LIQUID CRP CONTROLS |
RANDOX LABORATORIES, LTD. |
| K040379 |
02/17/2004 |
RANDOX IMMUNOASSAY CONTROL |
RANDOX LABORATORIES, LTD. |
| K000662 |
02/28/2000 |
RANDOX FERRITIN |
RANDOX LABORATORIES, LTD. |
| K961169 |
03/25/1996 |
RHEUMATOID FACTOR LATEX SLIDE TEST KIT |
RANDOX LABORATORIES, LTD. |
| K001009 |
03/29/2000 |
RANDOX C-REACTIVE PROTEIN |
RANDOX LABORATORIES, LTD. |
| K041142 |
04/30/2004 |
RANDOX CANNABINOIDS ASSSAY |
RANDOX LABORATORIES, LTD. |
| K041143 |
04/30/2004 |
RANDOX BARBITURATE ASSAY |
RANDOX LABORATORIES, LTD. |
| K041144 |
04/30/2004 |
RANDOX OPIATES ASSAY |
RANDOX LABORATORIES, LTD. |
| K011393 |
05/07/2001 |
RANDOX PHENYTOIN |
RANDOX LABORATORIES, LTD. |
| K031608 |
05/22/2003 |
RANDOX LIQUID PROTEIN CALIBRATOR |
RANDOX LABORATORIES, LTD. |
| K972608 |
06/11/1997 |
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL |
RANDOX LABORATORIES, LTD. |
| K972220 |
06/12/1997 |
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT |
RANDOX LABORATORIES, LTD. |
| K012319 |
07/23/2001 |
RANDOX HUMAN ASSSAYED DRUG CONTROL |
RANDOX LABORATORIES, LTD. |
| K092258 |
07/28/2009 |
RANDOX METABOLITE (EDDP) ASSAY |
RANDOX LABORATORIES, LTD. |
| K092273 |
07/28/2009 |
RANDOX ETHANOL ASSAY |
RANDOX LABORATORIES, LTD. |
| K092275 |
07/28/2009 |
RANDOX ECSTASY (MDMA) ASSAY |
RANDOX LABORATORIES, LTD. |
| K003346 |
10/25/2000 |
RANDOX GLUCOSE (GOD/PAP) |
RANDOX LABORATORIES, LTD. |
| K043071 |
11/08/2004 |
RANDOX PHENCYCLIDINE ASSAY |
RANDOX LABORATORIES, LTD. |
| K043266 |
11/26/2004 |
RANDOX URINE CONTROLS |
RANDOX LABORATORIES, LTD. |
| K043267 |
11/26/2004 |
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 |
RANDOX LABORATORIES, LTD. |
| K974605 |
12/10/1997 |
RANDOX INORGANIC PHOSPHOROUS |
RANDOX LABORATORIES, LTD. |
| K974606 |
12/10/1997 |
RANDOX MAGNESIUM |
RANDOX LABORATORIES, LTD. |
| K974607 |
12/10/1997 |
RANDOX CALCIUM |
RANDOX LABORATORIES, LTD. |
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