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510(k) K820840

CULTURE MEDIA, GENERAL NUTRIENT BROTH by Blue Ridge Media Co. — Product Code JSC

K820840 is an FDA 510(k) premarket notification submitted by Blue Ridge Media Co. for the device "CULTURE MEDIA, GENERAL NUTRIENT BROTH". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. 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
Culture Media, General Nutrient Broth
Device Class
Class I
Regulation Number
866.2350
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)
  • K820843 — CULTURE MEDIA SELECTIVE BROTH (April 16, 1982)
  • K820849 — BLUE RIDGE RABBIT BLOOD (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 JSC

  • K850143 — SPORDEX CULTURE MEDIA (March 5, 1985)
  • K842852 — BRAIN HEART INFUSION BROTH (August 3, 1984)
  • K842849 — TRYPTICASE SOY BROTH (August 3, 1984)
  • K841221 — BRAIN HEART INFUSION BROTH (April 4, 1984)
  • K841219 — SHOPPED MEAT CARBOHYDRATE (April 4, 1984)
  • K833300 — SABOURAUD BHI AGAR (November 7, 1983)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832570 — EXTRACT BROTH (September 12, 1983)
  • K832569 — INFUSION BROTH (September 12, 1983)
  • K832619 — THIOGLYCOLLATE MEDIUM (September 12, 1983)

FDA data resources