ENRICHED CULTURE MEDIUM— 510(k) K850735

Clearance details

Applicant

Roseville Medical Laboratoriesu

Product code

Code KZI

Device class

Class 1

Regulation

21 CFR 866.2330

Advisory panel

Microbiology

Date received

1985-02-20

Decision date

1985-03-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Roseville, CA, US

• K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)1988-10-25
• K881995 — DIAMOND'S MEDIUM MODIFIED1988-06-02
• K880122 — MIDDLEBROOK 7H9 BROTH1988-03-31
• K880131 — LOWENSTEIN-JENSEN, GRUFT1988-03-31
• K880134 — MIDDLEBROOK 7H11 AGAR1988-03-31

• K850731 — CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING1985-03-20
• K850732 — CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI1985-03-20
• K850733 — MULTIPURPOSE CULTURE MEDIUM1985-03-20
• K850734 — DIFFERENTIAL CULTURE MEDIUM1985-03-20
• K850736 — SELECTIVE CULTURE MEDIUM1985-03-20

Malfunction

2,834

Total

2,834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →