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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cyclosporine Radioimmunoassay
510(k) Number K813523
Device Name ELECTRIC SELF STERILIZATION INOCUL. LOOP
Applicant
Techhnilab Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Techhnilab Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1235
Classification Product Code
LTB  
Date Received12/16/1981
Decision Date 12/31/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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