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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K861211
Device Name MONO ACU-SLIDE TEST
Applicant
Cal-Tech Diagnostics, Inc.
1110 Monterey Pass Rd.
Monterey Park,  CA  91754
Applicant Contact CHEN, PH.D.
Correspondent
Cal-Tech Diagnostics, Inc.
1110 Monterey Pass Rd.
Monterey Park,  CA  91754
Correspondent Contact CHEN, PH.D.
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received03/31/1986
Decision Date 11/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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