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 Feb 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 230 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 25, 1985
Date Received
Dec 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
510(k) Exempt

Other clearances by Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (Nov 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (Mar 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (Jan 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (Dec 17, 1993)
  • K933679 — SIGMA BUN REAGENT (Dec 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (Dec 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (Dec 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (Oct 22, 1993)
  • K933697 — SIGMA CRE REAGENT (Oct 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (Oct 13, 1993)

Other clearances for product code HZA

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

FDA data resources

Source: FDA 510(k) database entry for K844808. Report a data issue: hello@regdatalab.com.