ACP— 510(k) K991010
Substantially EquivalentAbbott Diagnostics Mfg., Inc.
FDA 510(k) clearance K991010 for ACP, Substantially Equivalent on 1999-05-19. Applicant: Abbott Diagnostics Mfg., Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Diagnostics Mfg., Inc.
- Product code
- Code CKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.1020
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.