Name: Predicase
Price: 199 USD

K-number	K990941
Device name	NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
Applicant	Humagen Fertility Diagnostics, Inc.
Product code	MQK
Device class	Class II
Decision date	Jul 14, 1999
Decision	Substantially Equivalent
Regulation	884.6160

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 →

NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L

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