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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K954029
Device Name TESTPACK PLUS HCG URINE
Applicant
Abbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact JOY C SONSALLA
Correspondent
Abbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact JOY C SONSALLA
Regulation Number862.1155
Classification Product Code
JHI  
Date Received08/28/1995
Decision Date 10/05/1995
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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