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510(k) K901243

CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST by Cel Labs Pty, Ltd. — Product Code LJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1990
Date Received
March 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Chlamydia Trachomatis
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

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