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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Blood Tube
510(k) Number K780544
Device Name DISC-PAK ROTATOR
Applicant
Techhnilab Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Techhnilab Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2050
Classification Product Code
GLE  
Date Received04/03/1978
Decision Date 04/24/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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