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510(k) K833515

BOUINS SOLUTION by Sigma Chemical Co. — Product Code IGN

K833515 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "BOUINS SOLUTION". The FDA issued a decision of Substantially Equivalent on November 14, 1983. The device falls under product code IGN (Fluid, Bouin'S), a Class I device regulated under 21 CFR 864.4010. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1983
Date Received
October 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluid, Bouin'S
Device Class
Class I
Regulation Number
864.4010
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)

Other clearances for product code IGN

  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)

FDA data resources