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510(k) K821574

EOSIN Y SOLUTIN, AGUEOUS by Sigma Chemical Co. — Product Code HYB

K821574 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "EOSIN Y SOLUTIN, AGUEOUS". The FDA issued a decision of Substantially Equivalent on June 10, 1982. The device falls under product code HYB (Eosin Y), 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
June 10, 1982
Date Received
May 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eosin Y
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 HYB

  • K893663 — INSTANT EOSIN-AQUEOUS (June 13, 1989)
  • K880596 — EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE (March 31, 1988)
  • K880240 — INSTANT EOSIN-ALCOHOLIC (March 3, 1988)
  • K843426 — EOSIN Y 1% ALCOHOLIC (September 27, 1984)
  • K822982 — MIDAS 100 HEMACOLOR STAIN #66030 (October 27, 1982)
  • K821573 — EOSIN Y SOLUTION ALCHOLIC (June 9, 1982)
  • K811797 — EOSIN-Y (July 28, 1981)
  • K811826 — EOSIN Y (July 10, 1981)
  • K800942 — VOLU-SOL EOSIN Y STAIN (May 8, 1980)

FDA data resources