IPA FOR DETECTION OF PHENOBARBITAL
FDA 510(k) clearance K821543 · decided 1982-06-03
Clearance details
- K-number
- K821543
- Device name
- IPA FOR DETECTION OF PHENOBARBITAL
- Applicant
- Electro-Nucleonics Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-24
- Decision date
- 1982-06-03
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- LFN
- 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
+ Add to Predicate Builder ◉ Watch Electro-Nucleonics Laboratories
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 |
|---|---|---|
| QMS PHENOBARBITAL (K934388) | Seradyn, Inc. | 1994-02-25 |
| DART PHENOBARBITAL ASSAY SYSTEM (K864612) | Coulter Electronics, Inc. | 1987-01-13 |
| DUPONT PHENOBARBITAL ASSAY (K860304) | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 |
| DUPONT PHENOBARBITAL CALIBRATOR (K860303) | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 |
Recalls involving this device
No recalls on record reference this clearance.