MIDDLEBROOK 7H10 AGAR— 510(k) K870646

Name: FDA 510(k) clearance K870646
Creator: U.S. Food and Drug Administration
Published: 1987-04-14

Substantially Equivalent

Hardy Media

FDA 510(k) clearance K870646 for MIDDLEBROOK 7H10 AGAR, Substantially Equivalent on 1987-04-14. Applicant: Hardy Media. Device class: 1.

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

Download summary PDF View on FDA.gov ↗

Recent devices under product code KZI

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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

More clearances from Hardy Media

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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

Adverse events under product code KZI

product code KZI

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.