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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K852107
Device Name SICKLE-CHEX
Applicant
Streck Laboratories, Inc.
P.O. Box 37625
Omaha,  NE  68137
Applicant Contact HAL SORNSON
Correspondent
Streck Laboratories, Inc.
P.O. Box 37625
Omaha,  NE  68137
Correspondent Contact HAL SORNSON
Date Received05/15/1985
Decision Date 07/05/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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