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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Culture Media, Single Biochemical Test
510(k) Number K812465
Device Name PHOS MICROTUBES
Applicant
Carr Microbiologicals
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Carr Microbiologicals
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2320
Classification Product Code
JSF  
Date Received08/31/1981
Decision Date 09/14/1981
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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