Name: Predicase
Price: 199 USD

K-number	K050305
Device name	ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
Applicant	Bioscreen Medical, Inc.
Product code	LCX
Device class	Class II
Decision date	May 23, 2005
Decision	Substantially Equivalent
Regulation	862.1155

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View the full FDA submission: accessdata.fda.gov

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ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2

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