K-number	K900019
Device name	ROCKET REFERENCE PLASMA, CAT NO. 5188
Applicant	Helena Laboratories
Product code	GGN
Device class	Class II
Decision date	Jan 25, 1990
Decision	Substantially Equivalent
Regulation	864.5425

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View the full FDA submission: accessdata.fda.gov

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ROCKET REFERENCE PLASMA, CAT NO. 5188

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