ROMCHECK SPECIMEN COLLECTION KIT— 510(k) K900225
Substantially EquivalentAdeza Biomedical
FDA 510(k) clearance K900225 for ROMCHECK SPECIMEN COLLECTION KIT, Substantially Equivalent on 1990-02-02. Applicant: Adeza Biomedical. Device class: 1.
Clearance details
- Applicant
- Adeza Biomedical
- Product code
- Code LIO
- Device class
- Class 1
- Regulation
- 21 CFR 866.2900
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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More clearances from Adeza Biomedical
view allRecalls naming K900225
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 K900225.
Data sourced from openFDA. This site is unofficial and independent of the FDA.