Name: Predicase
Price: 199 USD

K-number	K023889
Device name	WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
Applicant	Wiener Laboratories Saic
Product code	MIU
Device class	Class I
Decision date	Feb 11, 2004
Decision	Substantially Equivalent
Regulation	866.3870

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254

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