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510(k) K832953

MUCICARMINE STAIN, #HT30 by Sigma Chemical Co. — Product Code HZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
August 31, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mucicarmine
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

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  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

Other clearances for product code HZC

  • K842925 — MUCI-CARMINE STAIN, MAYER'S FORMULA (September 11, 1984)