THEOPHYLLINE RIASSAY
FDA 510(k) clearance K792062 · decided 1980-02-25
Clearance details
- K-number
- K792062
- Device name
- THEOPHYLLINE RIASSAY
- Applicant
- Ria Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1979-10-15
- Decision date
- 1980-02-25
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- LCA
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THEOPHYLLINE TEST KIT REF. #A874799 (K880291) | Photec Diagnostics, Inc. | 1988-03-24 |
| PHASE II THEOPHYLLINE RADIOIMMUNOASSAY (K833789) | Medical & Scientific Designs, Inc. | 1984-01-24 |
| QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. (K821862) | Kallestad Laboratories, Inc. | 1982-07-06 |
| BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. (K821347) | Bioclinical Corp. | 1982-05-28 |
Recalls involving this device
No recalls on record reference this clearance.