ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K— 510(k) K010844
Substantially EquivalentAstoria-Pacific, Inc.
FDA 510(k) clearance K010844 for ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K, Substantially Equivalent on 2001-09-21. Applicant: Astoria-Pacific, Inc.. Device class: 2.
Clearance details
- Applicant
- Astoria-Pacific, Inc.
- Product code
- Code NAK
- Device class
- Class 2
- Regulation
- 21 CFR 862.1118
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clakamas, OR, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.