BETA QUIK STICK

Visual, Pregnancy Hcg, Prescription Use

PACIFIC BIOTECH, INC.

The following data is part of a premarket notification filed by Pacific Biotech, Inc. with the FDA for Beta Quik Stick.

Pre-market Notification Details

Device IDK860965
510k NumberK860965
Device Name:BETA QUIK STICK
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant PACIFIC BIOTECH, INC. 9050 CAMINO SANTA FE San Diego,  CA  92121
ContactShu-ching Cheng
CorrespondentShu-ching Cheng
PACIFIC BIOTECH, INC. 9050 CAMINO SANTA FE San Diego,  CA  92121
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-13
Decision Date1986-04-24

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