K-number	K964462
Device name	ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
Applicant	Teco Diagnostics
Product code	JHI
Device class	Class II
Decision date	Feb 11, 1997
Decision	Substantially Equivalent
Regulation	862.1155

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View the full FDA submission: accessdata.fda.gov

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ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST

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