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510(k) K820843

CULTURE MEDIA SELECTIVE BROTH by Blue Ridge Media Co. — Product Code JSD

K820843 is an FDA 510(k) premarket notification submitted by Blue Ridge Media Co. for the device "CULTURE MEDIA SELECTIVE BROTH". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. 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, Selective Broth
Device Class
Class I
Regulation Number
866.2360
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)
  • 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 JSD

  • K883075 — FASTIDIOUS INOCULUM BROTH (August 15, 1988)
  • K880107 — CAMPY BROTH (March 30, 1988)
  • K873324 — SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (October 2, 1987)
  • K873218 — BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 (September 23, 1987)
  • K871447 — TODD HEWITT W/CNA (LIM BROTH) (May 13, 1987)
  • K871640 — ALKALINE PEPTONE WATER (May 13, 1987)
  • K870594 — T9802 TSB W/6.5% NACL (March 30, 1987)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K844547 — TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (January 16, 1985)
  • K841836 — SELECTIVE CULTURE MED. TRICHOMONAS (May 14, 1984)

FDA data resources