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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Allergen And Vaccine Delivery Needles
510(k) Number K961918
FOIA Releasable 510(k) K961918
Device Name MULTI-TEST II
Applicant
Lincoln Diagnostics, Inc.
Hickory Pt. Rd. Box 1128
Decatur,  IL  62525
Applicant Contact GARY L HENI
Correspondent
Lincoln Diagnostics, Inc.
Hickory Pt. Rd. Box 1128
Decatur,  IL  62525
Correspondent Contact GARY L HENI
Regulation Number880.5570
Classification Product Code
SCL  
Date Received05/17/1996
Decision Date 08/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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