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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lambda, Antigen, Antiserum, Control
510(k) Number K841864
Device Name QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
Applicant
Kallestad Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kallestad Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5550
Classification Product Code
DEH  
Date Received05/04/1984
Decision Date 07/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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