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510(k) K893530

IRISTAIN FORMULA 2, PARTS 1 AND 2 by Intl. Remote Imaging Systems — Product Code JTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1989
Date Received
May 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Microbiologic
Device Class
Class I
Regulation Number
864.1850
Review Panel
MI
Submission Type

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