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510(k) K820849

BLUE RIDGE RABBIT BLOOD by Blue Ridge Media Co. — Product Code LHW

K820849 is an FDA 510(k) premarket notification submitted by Blue Ridge Media Co. for the device "BLUE RIDGE RABBIT BLOOD". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code LHW (Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment), a Class I device regulated under 21 CFR 866.3720. Blue Ridge Media Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1982
Date Received
March 26, 1982
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 Blue Ridge Media Co.

  • K820846 — ANTIMICROBIAL SUSCEP. TEST, MUELLER (April 16, 1982)
  • K820848 — BLUE RIDGE SHEEP BLOOD (April 16, 1982)
  • K820842 — CULTURE MEDIA, NON-SELECTIVE/DIFFER (April 16, 1982)
  • K820840 — CULTURE MEDIA, GENERAL NUTRIENT BROTH (April 16, 1982)
  • K820843 — CULTURE MEDIA SELECTIVE BROTH (April 16, 1982)
  • K820845 — DULTURE MEDIA, SELECTIVE & NON-DIFFER (April 16, 1982)
  • K820844 — CULTURE MEDIA, SELECTIVE & DIFFERENTIAL (April 16, 1982)
  • K820841 — CULTURE MEDIA, MULTIPLE BIOCHEMICAL (April 16, 1982)
  • K820847 — ISOLATION OF PATHOGENIC NEISSERIA (April 16, 1982)
  • K820839 — CULTURE MEDIA, SINGLE BIOCHEM. TEST (April 16, 1982)

Other clearances for product code LHW

  • K820848 — BLUE RIDGE SHEEP BLOOD (April 16, 1982)
  • K813513 — AFRICAN GREEN MONKEY BLOOD IN ALSERVERS (December 31, 1981)
  • K813512 — RHESUS MONKEY BLOOD IN ALSEVER'S (December 29, 1981)

FDA data resources