ACON UTI URINARY TRACT INFECTION TEST STRIPS

Test, Urine Leukocyte

ACON LABORATORIES, INC.

The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Uti Urinary Tract Infection Test Strips.

Pre-market Notification Details

Device IDK063295
510k NumberK063295
Device Name:ACON UTI URINARY TRACT INFECTION TEST STRIPS
ClassificationTest, Urine Leukocyte
Applicant ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego,  CA  92121
ContactJinn-nan Lin
CorrespondentJinn-nan Lin
ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego,  CA  92121
Product CodeLJX  
CFR Regulation Number864.7675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-01
Decision Date2007-10-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00722066003404 K063295 000
50096295135850 K063295 000
20682607651003 K063295 000
00023513000039 K063295 000
00860002060484 K063295 000
00850024942073 K063295 000
00023513487441 K063295 000
00810038633473 K063295 000
10810038631445 K063295 000

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