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510(k) K842440

SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH by Anco Medical Reagents & Assoc. — Product Code JPK

K842440 is an FDA 510(k) premarket notification submitted by Anco Medical Reagents & Assoc. for the device "SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH". The FDA issued a decision of Substantially Equivalent on July 27, 1984. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Anco Medical Reagents & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1984
Date Received
June 21, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Hematology Quality Control
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Anco Medical Reagents & Assoc.

  • K831871 — SICKLE-HEME A/S CONTROLS & A/A CONTROL (July 28, 1983)
  • K821658 — HEMOGLOBIN REAGENT (June 25, 1982)
  • K821526 — ACID PHOSPHATASE REAGENT SET (June 10, 1982)
  • K821102 — MEGNESIUM REAGENT KIT (May 5, 1982)
  • K820951 — ENZYMATIC CHOLESTEROL KIT (April 26, 1982)
  • K820466 — SGOT REAGENT SET (March 11, 1982)
  • K820491 — SGPT REAGENT SET (March 11, 1982)
  • K820500 — TOTAL LIPID REAGENT SET (March 11, 1982)
  • K812837 — ALKALINE PHOSPHATASE REAGENT SET (January 29, 1982)
  • K813415 — UREA NITROGEN REAGENT SET (December 31, 1981)

Other clearances for product code JPK

  • K160586 — XN-L CHECK (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141964 — XN CHECK (December 5, 2014)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K120742 — XN CHECK (October 19, 2012)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)

FDA data resources