IN VITRO PHENOBARBITAL RIA TEST
FDA 510(k) clearance K772111 · decided 1977-11-28
Clearance details
- K-number
- K772111
- Device name
- IN VITRO PHENOBARBITAL RIA TEST
- Applicant
- Clinical Assays, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-11-07
- Decision date
- 1977-11-28
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- DKP
- Device class
- 2
- Regulation number
- 862.3660
- 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 |
|---|---|---|
| ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT (K844167) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-27 |
| FLUOROMATIC PHENOLBARBITAL FIA (K800090) | Bio-Rad | 1980-01-23 |
Recalls involving this device
No recalls on record reference this clearance.