ACP
FDA 510(k) clearance K991010 · decided 1999-05-19
Clearance details
- K-number
- K991010
- Device name
- ACP
- Applicant
- Abbott Diagnostics Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-26
- Decision date
- 1999-05-19
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- CKB
- Device class
- 2
- Regulation number
- 862.1020
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Diagnostics Mfg.
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.