510(k) K792062
- Device
- Theophylline Riassay
- Applicant
- RIA DIAGNOSTICS
- 510(k) number
- K792062
- Product code
- LCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-02-25
- Date received
- 1979-10-15
- Regulation
- 862.3880
- Classification name
- Radioimmunoassay, Theophylline
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical 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 LCA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K880291 | THEOPHYLLINE TEST KIT REF. #A874799 | Photec Diagnostics, Inc. | 1988-03-24 |
| K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | Medical & Scientific Designs, Inc. | 1984-01-24 |
| K821862 | QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. | Kallestad Laboratories, Inc. | 1982-07-06 |
| K821347 | BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. | Bioclinical Corp. | 1982-05-28 |