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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K943780
Device Name NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
Applicant
HERAEUS KULZER, INC.
1127 MYRTLE ST.
ELKHART,  IN  46514
Applicant Contact ROSANNE M SAVOL
Correspondent
HERAEUS KULZER, INC.
1127 MYRTLE ST.
ELKHART,  IN  46514
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.1660
Classification Product Code
JJW  
Date Received08/03/1994
Decision Date 10/31/1994
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
Recalls CDRH Recalls
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