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510(k) K813512

RHESUS MONKEY BLOOD IN ALSEVER'S by Dutchland Laboratories, Inc. — Product Code LHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1981
Date Received
December 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
Submission Type

Other clearances by Dutchland Laboratories, Inc.

  • K821911 — S-MEM-JOKLIK'S POWDER (July 27, 1982)
  • K821918 — POWDERED RPMI-1603 MEDIUM (July 27, 1982)
  • K821912 — MCCOY'S POWDER MEDIUM 5A SUSPENSION (July 27, 1982)
  • K821919 — POWDERED RPMI-1634 MEDIUM (July 27, 1982)
  • K821914 — COON'S F-12 POWDER MEDIUM (July 27, 1982)
  • K821916 — IMPROVED MEM-RICHTER'S POWDER MODIF. (July 27, 1982)
  • K821913 — ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM (July 27, 1982)
  • K821917 — WAYMOUTH'S POWDER MEDIUM (July 27, 1982)
  • K821915 — BME AUTOCLAVABLE MEDIUM (July 27, 1982)
  • K820930 — FISCHER'S POWDERED MEDIUM (April 21, 1982)

Other clearances for product code LHW

  • K820849 — BLUE RIDGE RABBIT BLOOD (April 16, 1982)
  • K820848 — BLUE RIDGE SHEEP BLOOD (April 16, 1982)
  • K813513 — AFRICAN GREEN MONKEY BLOOD IN ALSERVERS (December 31, 1981)