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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf, All, Mycoplasma Spp.
510(k) Number K834338
Device Name MYCOPLASMA PNEUMONIAE CF ANTIGEN
Applicant
Hillcrest Biologicals
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hillcrest Biologicals
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3375
Classification Product Code
GSB  
Date Received12/12/1983
Decision Date 02/27/1984
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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