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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k081150
B. Purpose for Submission:
New device
C. Measured:
Human Chorionic Gonadotrophin (HCG)
D.
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What is accessdata fda?
Accessdata FDA stands for Accessible Data FDA, which is a system created by the Food and Drug Administration to allow regulated industry to submit electronic regulatory information.
Who is required to file accessdata fda?
Manufacturers, importers, and distributors of FDA regulated products are required to file accessdata FDA.
How to fill out accessdata fda?
Accessdata FDA can be filled out electronically through the FDA Electronic Submissions Gateway (ESG).
What is the purpose of accessdata fda?
The purpose of accessdata FDA is to standardize the submission of regulatory information to the FDA to ensure data accuracy and compliance.
What information must be reported on accessdata fda?
Accessdata FDA must include information about the product, manufacturing processes, labeling, and any adverse events.
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