510(k) K821347
- Device
- BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.
- Applicant
- BIOCLINICAL CORP.
- 510(k) number
- K821347
- Product code
- LCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-05-28
- Date received
- 1982-05-05
- Regulation
- 862.3880
- Classification name
- Radioimmunoassay, Theophylline
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- 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 |
| K792062 | THEOPHYLLINE RIASSAY | Ria Diagnostics | 1980-02-25 |
Legacy Summary#
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FDA Review#
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