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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K851387
Device Name MICROSTATIC URINE TRANSPORT TUBE FOR C & S
Applicant
Analytical Luminescence Laboratory, Inc.
11760 Sorrento Valley Rd.#E
San Diego,  CA  92121
Applicant Contact JON C WANNLUND
Correspondent
Analytical Luminescence Laboratory, Inc.
11760 Sorrento Valley Rd.#E
San Diego,  CA  92121
Correspondent Contact JON C WANNLUND
Regulation Number866.2900
Classification Product Code
LIO  
Date Received04/09/1985
Decision Date 05/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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