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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
Recalls CDRH Recalls
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