TDX(R) AMYLASE II— 510(k) K863622
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K863622 for TDX(R) AMYLASE II, Substantially Equivalent on 1986-10-03. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abbott Park, IL, US
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More clearances from Abbott Laboratories
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