510(k) K880291
- Device
- THEOPHYLLINE TEST KIT REF. #A874799
- Applicant
- PHOTEC DIAGNOSTICS, INC.
- 510(k) number
- K880291
- Product code
- LCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-24
- Date received
- 1988-01-25
- 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#
- Contact
- ROBERT P HENRY
- Address
- 101 E. Main St. Little Falls NJ US 07424 07424
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LCA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K792062 | THEOPHYLLINE RIASSAY | Ria Diagnostics | 1980-02-25 |
Legacy Summary#
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FDA Review#
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