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510(k) K850736

SELECTIVE CULTURE MEDIUM by Roseville Medical Laboratoriesu — Product Code JSI

K850736 is an FDA 510(k) premarket notification submitted by Roseville Medical Laboratoriesu for the device "SELECTIVE CULTURE MEDIUM". The FDA issued a decision of Substantially Equivalent on March 20, 1985. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Roseville Medical Laboratoriesu has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
February 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

Other clearances by Roseville Medical Laboratoriesu

  • K850731 — CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING (March 20, 1985)
  • K850734 — DIFFERENTIAL CULTURE MEDIUM (March 20, 1985)
  • K850733 — MULTIPURPOSE CULTURE MEDIUM (March 20, 1985)
  • K850732 — CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI (March 20, 1985)
  • K850738 — SUPPLEMENT FOR CULTURE MEDIUM (March 20, 1985)
  • K850737 — TRANSPORT CULTURE MEDIUM (March 20, 1985)
  • K850735 — ENRICHED CULTURE MEDIUM (March 16, 1985)

Other clearances for product code JSI

  • K070691 — BBL CHROMAGAR 0157 (November 20, 2007)
  • K974428 — DIPSTREAK (July 30, 1998)
  • K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM (June 9, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K882182 — SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (June 6, 1988)
  • K881572 — XL AGAR BASE (April 18, 1988)
  • K881576 — SELENITE BROTH (April 18, 1988)
  • K881575 — SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)
  • K881555 — TINSDALE AGAR BASE (April 18, 1988)
  • K881577 — MODIFIED SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)

FDA data resources