CHOCOLATE AGAR— 510(k) K864238

Name: FDA 510(k) clearance K864238
Creator: U.S. Food and Drug Administration
Published: 1987-03-31

Substantially Equivalent

Mds Laboratories, Inc.

FDA 510(k) clearance K864238 for CHOCOLATE AGAR, Substantially Equivalent on 1987-03-31. Applicant: Mds Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Mds Laboratories, Inc.
Product code: Code KZI
Device class: Class 1
Regulation: 21 CFR 866.2330
Advisory panel: Microbiology
Date received: 1986-10-28
Decision date: 1987-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: L5j 2m4, CA

Download summary PDF View on FDA.gov ↗

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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 Mds Laboratories, Inc.

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K864237 — CARY BLAIR TRANSPORT MEDIUM1987-03-31
K864239 — CLED AGAR WITH ANDRADES INDICATOR1987-03-31
K864240 — COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD1987-03-31
K864241 — DNASE AGAR1987-03-31
K864242 — HEKTOEN ENTERIC AGAR1987-03-31

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.