Panels › Clinical Toxicology › Product code JXN · Class 2
Enzyme Immunoassay, Propoxyphene
Regulation 862.3700
0510(k)s in 12 months (22 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in JXN
| Company | 510(k)s | Recalls |
|---|---|---|
| Syva Co. | 4 | 0 |
| Abbott Laboratories | 2 | 0 |
| Roche Diagnostic Systems, Inc. | 2 | 0 |
| ACON Laboratories, Inc. | 1 | 0 |
| Alfa Scientific Designs, Inc. | 1 | 0 |
| American Bio Medica Corp. | 1 | 0 |
| Beckman Instruments, Inc. | 1 | 0 |
| Branan Medical Corp. | 1 | 0 |
| Diagnostic Reagents, Inc. | 1 | 0 |
| Express Diagnostics Int'l., Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2011 | Express Diagnostics Int'l., Inc. DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 610 Terminated |
JXN | None listed |
| Sep 17, 2008 | Sun Biomedical Laboratories, Inc. VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. Terminated |
JXN | None listed |
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