Panels › Clinical Toxicology › Product code LER · Class 2
Fluorescent Immunoassay, Theophylline
Regulation 862.3880
0510(k)s in 12 months (15 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LER
| Company | 510(k)s | Recalls |
|---|---|---|
| Miles Laboratories, Inc. | 3 | 0 |
| 3M Company | 1 | 0 |
| Abbott Diagnostic International, Ltd. | 0 | 1 |
| Abbott Laboratories | 1 | 0 |
| American Diagnostic Corp. | 1 | 0 |
| Bio-Rad | 1 | 0 |
| Hoffmann-La Roche, Inc. | 1 | 0 |
| Microgenics Corp. | 1 | 0 |
| Paragon Diagnostics, Inc. | 1 | 0 |
| Sclavo, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 13, 1994 | K942192 | THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS Sigma Diagnostics, Inc. | LER |
| Dec 26, 1990 | K905521 | CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION Microgenics Corp. | LER |
| Nov 10, 1988 | K882570 | TURBOX THEOPHYLLINE ASSAY Unipath , Ltd., GB | LER |
| Dec 22, 1986 | K864409 | IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS Sclavo, Inc. | LER |
| Nov 5, 1986 | K863475 | THEOFAST(TM) TEST PACKAGE 3M Company | LER |
| Sep 26, 1984 | K842585 | THEOPHYLLINE KIT FLUORESCENCE POLARIZA- Windsor Laboratories, Inc. | LER |
| Apr 4, 1984 | K840758 | IMMPULSE THEOPHYLLINE ASSAY REAGENTS Paragon Diagnostics, Inc. | LER |
| Nov 14, 1983 | K833070 | TDX THEOPHYLLINE Abbott Laboratories | LER |
| Jun 30, 1983 | K831514 | AMWA TDA THEOPHYLLINE TEST Miles Laboratories, Inc. | LER |
| Jan 7, 1983 | K823576 | COBAS STANDARD FOR TOTAL PROTEIN Hoffmann-La Roche, Inc. | LER |
| Mar 2, 1982 | K820397 | AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM American Diagnostic Corp. | LER |
| Dec 3, 1981 | K813240 | EMIT-AAD THEOPHYLLINE ASSAY Syva Co. | LER |
| Sep 23, 1981 | K812518 | AMES TDA THEOPHYLLINE TEST Miles Laboratories, Inc. | LER |
| Jul 10, 1981 | K811856 | FLUOROMATIC THEOPHYLLINE FIA Bio-Rad | LER |
| Apr 17, 1981 | K810943 | AMES TDA THEOPHYLLINE TEST Miles Laboratories, Inc. | LER |
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