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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 Apr 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 10 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 16, 1982
Date Received
Mar 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
510(k) Exempt

Other clearances by Blue Ridge Media Co.

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

Other clearances for product code LHW

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

FDA data resources

Source: FDA 510(k) database entry for K820849. Report a data issue: hello@regdatalab.com.