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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf, Psittacosis (Chlamydia Group)
510(k) Number K811570
Device Name ANTIBODY TO CHLAMYDIA TRACHOMATIS
Applicant
Electro-Nucleonics Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Electro-Nucleonics Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3120
Classification Product Code
GPW  
Date Received06/04/1981
Decision Date 07/23/1981
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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