THEOPHYLLINE TEST KIT REF. #A874799
FDA 510(k) clearance K880291 · decided 1988-03-24
Clearance details
- K-number
- K880291
- Device name
- THEOPHYLLINE TEST KIT REF. #A874799
- Applicant
- Photec Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-25
- Decision date
- 1988-03-24
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- LCA
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Little Falls, NJ, 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 |
|---|---|---|
| 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 |
| THEOPHYLLINE RIASSAY (K792062) | Ria Diagnostics | 1980-02-25 |
Recalls involving this device
No recalls on record reference this clearance.