510(k) K831514
- Device
- AMWA TDA THEOPHYLLINE TEST
- Applicant
- MILES LABORATORIES, INC.
- 510(k) number
- K831514
- Product code
- LER
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-30
- Date received
- 1983-05-12
- Regulation
- 862.3880
- Classification name
- Fluorescent Immunoassay, Theophylline
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LER #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942192 | THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | 1994-07-13 |
| K905521 | CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION | Microgenics Corp. | 1990-12-26 |
| K882570 | TURBOX THEOPHYLLINE ASSAY | Unipath , Ltd. | 1988-11-10 |
| K864409 | IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS | Sclavo, Inc. | 1986-12-22 |
| K863475 | THEOFAST(TM) TEST PACKAGE | 3M Company | 1986-11-05 |
| K842585 | THEOPHYLLINE KIT FLUORESCENCE POLARIZA- | Windsor Laboratories, Inc. | 1984-09-26 |
| K840758 | IMMPULSE THEOPHYLLINE ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-04-04 |
| K833070 | TDX THEOPHYLLINE | Abbott Laboratories | 1983-11-14 |
| K823576 | COBAS STANDARD FOR TOTAL PROTEIN | Hoffmann-La Roche, Inc. | 1983-01-07 |
| K820397 | AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM | American Diagnostic Corp. | 1982-03-02 |
| K813240 | EMIT-AAD THEOPHYLLINE ASSAY | Syva Co. | 1981-12-03 |
| K812518 | AMES TDA THEOPHYLLINE TEST | Miles Laboratories, Inc. | 1981-09-23 |
| K811856 | FLUOROMATIC THEOPHYLLINE FIA | Bio-Rad | 1981-07-10 |
| K810943 | AMES TDA THEOPHYLLINE TEST | Miles Laboratories, Inc. | 1981-04-17 |
Legacy Summary#
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FDA Review#
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