Home / 510(k) Clearances / K844808

510(k) K844808

METHYL GREEN-PYRONIN STAIN PROCEDURE HT70 by Sigma Chemical Co. — Product Code HZA

K844808 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "METHYL GREEN-PYRONIN STAIN PROCEDURE HT70". The FDA issued a decision of Substantially Equivalent on February 25, 1985. The device falls under product code HZA (Methyl Green), 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
February 25, 1985
Date Received
December 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Green
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)

Other clearances for product code HZA

  • K871544 — METHYL GREEN SOLUTION (April 29, 1987)

FDA data resources