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510(k) K883052

METHENO-STAIN KIT by Scientific Device Laboratory, Inc. — Product Code JTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1988
Date Received
July 19, 1988
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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  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)
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  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K883049 — ATS PARA-SET IODINE ALCOHOL SOLUTION (August 17, 1988)