COOKED MEAT MEDIUM WITH IRON— 510(k) K870642

Clearance details

Applicant

Hardy Media

Product code

Code KZI

Device class

Class 1

Regulation

21 CFR 866.2330

Advisory panel

Microbiology

Date received

1987-02-13

Decision date

1987-04-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Santa Barbara, 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

• K880116 — MRVP BROTH1988-03-31
• K880119 — MOELLERS DECARBOXYLASE, ONITHINE1988-03-31
• K880120 — MOELLERS DECARBOXYLASE, LYSINE1988-03-31
• K880121 — MOELLERS DECARBOXYLASE, BASE1988-03-31
• K880123 — LOWENSTEIN-JENSEN SLANT1988-03-31

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 →