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510(k) K821038

FAST VIOLET B by Dms Laboratories — Product Code JTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1982
Date Received
April 13, 1982
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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  • K820211 — NINHYDRIN (February 12, 1982)
  • K820210 — IND (February 12, 1982)
  • K820212 — OXI (February 12, 1982)
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  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)
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  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)