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510(k) K820847

ISOLATION OF PATHOGENIC NEISSERIA by Blue Ridge Media Co. — Product Code JTY

K820847 is an FDA 510(k) premarket notification submitted by Blue Ridge Media Co. for the device "ISOLATION OF PATHOGENIC NEISSERIA". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. 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, For Isolation Of Pathogenic Neisseria
Device Class
Class II
Regulation Number
866.2410
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)
  • 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)
  • K820839 — CULTURE MEDIA, SINGLE BIOCHEM. TEST (April 16, 1982)

Other clearances for product code JTY

  • K210511 — InTray GC (October 20, 2021)
  • K993033 — INTRAY GC (December 16, 1999)
  • K954986 — GC BASE W/ 1% GCHI (February 16, 1996)
  • K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (June 30, 1995)
  • K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (February 9, 1994)
  • K933121 — MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (February 3, 1994)
  • K934331 — THAYER MARTIN, MODIFIED PILL POCKET (December 21, 1993)
  • K934330 — TRANSGROW (December 17, 1993)
  • K931864 — MARTIN LEWIS WITH LINOCMYCIN (December 15, 1993)
  • K881552 — PROTEOSE NO. 3 AGAR (April 18, 1988)

FDA data resources