OPUS PHENOBARBITAL TEST SYSTEM
FDA 510(k) clearance K896861 · decided 1990-01-11
Clearance details
- K-number
- K896861
- Device name
- OPUS PHENOBARBITAL TEST SYSTEM
- Applicant
- Pb Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-05
- Decision date
- 1990-01-11
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- DLZ
- Device class
- 2
- Regulation number
- 862.3660
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Westwood, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pb Diagnostic Systems
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.
Recalls involving this device
No recalls on record reference this clearance.