Home / 510(k) Clearances / K840798

510(k) K840798

AMYLOID STAIN, CONGO RED HT 60 by Sigma Chemical Co. — Product Code ICH

K840798 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "AMYLOID STAIN, CONGO RED HT 60". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code ICH (Congo Red), 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
March 12, 1984
Date Received
February 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Congo Red
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)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN 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)

FDA data resources