FDA 510(k) Applications Submitted by JOSEPH GINETE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150275 |
02/04/2015 |
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls |
Immunalysis Corporation |
| K150925 |
04/06/2015 |
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set |
Immunalysis Corporation |
| K131168 |
04/24/2013 |
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY |
Immunalysis Corporation |
| K161216 |
04/29/2016 |
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators |
IMMUNALYSIS CORPORATION |
| K151203 |
05/05/2015 |
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set |
IMMUNALYSIS CORPORATION |
| K151395 |
05/26/2015 |
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets |
Immunalysis Corporation |
| K141406 |
05/28/2014 |
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS |
Immunalysis Corporation |
| K161714 |
06/21/2016 |
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators |
IMMUNALYSIS CORPORATION |
| K151771 |
06/30/2015 |
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators |
IMMUNALYSIS CORPORATION |
| K141803 |
07/03/2014 |
IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY |
Immunalysis Corporation |
| K152176 |
08/04/2015 |
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators |
Immunalysis Corporation |
| K143500 |
12/10/2014 |
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set |
Immunalysis Corporation |
| K143502 |
12/10/2014 |
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls |
IMMUNALYSIS CORPORATION |
| K153693 |
12/23/2015 |
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators |
IMMUNALYSIS CORPORATION |
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