EOSIN Y SOLUTIN, AGUEOUS— 510(k) K821574

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K821574 for EOSIN Y SOLUTIN, AGUEOUS, Substantially Equivalent on 1982-06-10. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code HYB
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1982-05-27
Decision date: 1982-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HYB

K893663 — INSTANT EOSIN-AQUEOUS1989-06-13
K880596 — EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE1988-03-31
K880240 — INSTANT EOSIN-ALCOHOLIC1988-03-03
K843426 — EOSIN Y 1% ALCOHOLIC1984-09-27
K822982 — MIDAS 100 HEMACOLOR STAIN #660301982-10-27

More clearances from Sigma Chemical Co.

K933694 — SIGMA GLUCOSE REAGENT1994-11-04
K933678 — SIGMA CALCIUM REAGENT1994-03-11
K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT1994-01-03
K933679 — SIGMA BUN REAGENT1993-12-17
K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT1993-12-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.