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510(k) K850735

ENRICHED CULTURE MEDIUM by Roseville Medical Laboratoriesu — Product Code KZI

K850735 is an FDA 510(k) premarket notification submitted by Roseville Medical Laboratoriesu for the device "ENRICHED CULTURE MEDIUM". The FDA issued a decision of Substantially Equivalent on March 16, 1985. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. Roseville Medical Laboratoriesu has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1985
Date Received
February 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Enriched
Device Class
Class I
Regulation Number
866.2330
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)
  • K850736 — SELECTIVE CULTURE MEDIUM (March 20, 1985)
  • K850737 — TRANSPORT CULTURE MEDIUM (March 20, 1985)

Other clearances for product code KZI

  • K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (October 25, 1988)
  • K881995 — DIAMOND'S MEDIUM MODIFIED (June 2, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880131 — LOWENSTEIN-JENSEN, GRUFT (March 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)
  • K880109 — CYSTINE TRYPTIC MEDIUM BASE (March 30, 1988)
  • K880138 — WALLENSTEIN MEDIUM SLANT (March 30, 1988)
  • K880127 — POTATO DEXTROSE AGAR (March 7, 1988)
  • K874179 — BIOTIS (TM) SABHI (DOUBLE POUR) (January 28, 1988)
  • K874177 — BIOTIS (TM) BCYE (December 4, 1987)

FDA data resources