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510(k) K850732

CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI by Roseville Medical Laboratoriesu — Product Code JTY

K850732 is an FDA 510(k) premarket notification submitted by Roseville Medical Laboratoriesu for the device "CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI". The FDA issued a decision of Substantially Equivalent on March 20, 1985. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. 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, For Isolation Of Pathogenic Neisseria
Device Class
Class II
Regulation Number
866.2410
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)
  • K850738 — SUPPLEMENT FOR CULTURE MEDIUM (March 20, 1985)
  • K850736 — SELECTIVE CULTURE MEDIUM (March 20, 1985)
  • K850737 — TRANSPORT CULTURE MEDIUM (March 20, 1985)
  • K850735 — ENRICHED CULTURE MEDIUM (March 16, 1985)

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