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510(k) K820839

CULTURE MEDIA, SINGLE BIOCHEM. TEST by Blue Ridge Media Co. — Product Code JSF

K820839 is an FDA 510(k) premarket notification submitted by Blue Ridge Media Co. for the device "CULTURE MEDIA, SINGLE BIOCHEM. TEST". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. 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, Single Biochemical Test
Device Class
Class I
Regulation Number
866.2320
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)
  • K820847 — ISOLATION OF PATHOGENIC NEISSERIA (April 16, 1982)

Other clearances for product code JSF

  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (April 1, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (March 31, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880110 — CYSTINE TRYPTIC MEDIUM W/DEXTROSE (March 30, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (March 30, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (March 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (March 30, 1988)
  • K880139 — ONPG TEST REAGENT (March 30, 1988)
  • K880129 — BRILLIANT GREEN BILE BROTH (March 30, 1988)

FDA data resources