N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT— 510(k) K965100
Substantially EquivalentCrestat Diagnostics, Inc.
FDA 510(k) clearance K965100 for N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT, Substantially Equivalent on 1997-07-14. Applicant: Crestat Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Crestat Diagnostics, Inc.
- Product code
- Code DEM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5130
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Weston, CT, US
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More clearances from Crestat Diagnostics, Inc.
view allRecalls naming K965100
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K965100.
Data sourced from openFDA. This site is unofficial and independent of the FDA.