Name: Predicase
Price: 199 USD

K-number	K253153
Device name	SER Pen Carain MicroSystem (MP1209SP)
Applicant	Su-Ko Technologies, LLC
Product code	QAI
Device class	Class II
Decision date	Oct 29, 2025
Decision	Substantially Equivalent
Regulation	878.4430

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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SER Pen Carain MicroSystem (MP1209SP)

Everything you need for a 510(k) submission. Nothing you don't.