QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.
FDA 510(k) clearance K821862 · decided 1982-07-06
Clearance details
- K-number
- K821862
- Device name
- QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-24
- Decision date
- 1982-07-06
- Days to decision
- 12 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 |
| BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. (K821347) | Bioclinical Corp. | 1982-05-28 |
| THEOPHYLLINE RIASSAY (K792062) | Ria Diagnostics | 1980-02-25 |
Recalls involving this device
No recalls on record reference this clearance.