PHASE II THEOPHYLLINE RADIOIMMUNOASSAY
FDA 510(k) clearance K833789 · decided 1984-01-24
Clearance details
- K-number
- K833789
- Device name
- PHASE II THEOPHYLLINE RADIOIMMUNOASSAY
- Applicant
- Medical & Scientific Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-31
- Decision date
- 1984-01-24
- Days to decision
- 85 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
+ Add to Predicate Builder ◉ Watch Medical & Scientific Designs
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. (K821862) | Kallestad Laboratories, Inc. | 1982-07-06 |
| 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.