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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 Apr 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 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
Culture Media, Single Biochemical Test
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type
510(k) Exempt

Other clearances by Blue Ridge Media Co.

  • K820849 — BLUE RIDGE RABBIT BLOOD (Apr 16, 1982)
  • 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)

Other clearances for product code JSF

  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (Apr 1, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (Mar 31, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (Mar 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (Mar 31, 1988)
  • K880135 — NITRATE BROTH (Mar 30, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (Mar 30, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (Mar 30, 1988)
  • K880129 — BRILLIANT GREEN BILE BROTH (Mar 30, 1988)
  • K880139 — ONPG TEST REAGENT (Mar 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (Mar 30, 1988)

FDA data resources

Source: FDA 510(k) database entry for K820839. Report a data issue: hello@regdatalab.com.