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510(k) K894389

CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS by Catachem, Inc. — Product Code GGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1989
Date Received
July 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pipette, Sahli
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type

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