BARBITURATE ENZYME IMMUNOASSAY KIT
FDA 510(k) clearance K882663 · decided 1988-09-19
Clearance details
- K-number
- K882663
- Device name
- BARBITURATE ENZYME IMMUNOASSAY KIT
- Applicant
- General Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1988-06-27
- Decision date
- 1988-09-19
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- DIS
- Device class
- 2
- Regulation number
- 862.3150
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch General Diagnostics
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.