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510(k) K833273

MASSON TRICHROME STAIN HT15 by Sigma Chemical Co. — Product Code ICN

K833273 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "MASSON TRICHROME STAIN HT15". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code ICN (Biebrich Scarlet), a Class I device regulated under 21 CFR 864.1850. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1983
Date Received
September 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

Other clearances for product code ICN

  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)

FDA data resources