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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K021698
Device Name MY ALLERGY TEST
Applicant
IMMUNETECH CORPORATION
P.O. BOX 9433
17394 VIA DEL BRAVO
rancho santa fe,  CA  92067
Applicant Contact vivianne noetzel
Correspondent
IMMUNETECH CORPORATION
P.O. BOX 9433
17394 VIA DEL BRAVO
rancho santa fe,  CA  92067
Correspondent Contact vivianne noetzel
Regulation Number862.1675
Classification Product Code
JKA  
Date Received05/22/2002
Decision Date 09/19/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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