SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300— 510(k) K873321

Name: FDA 510(k) clearance K873321
Creator: U.S. Food and Drug Administration
Published: 1987-09-29

Substantially Equivalent

Lakewood Biochemical Co., Inc.

FDA 510(k) clearance K873321 for SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300, Substantially Equivalent on 1987-09-29. Applicant: Lakewood Biochemical Co., Inc.. Device class: 1.

Clearance details

Applicant: Lakewood Biochemical Co., Inc.
Product code: Code KZI
Device class: Class 1
Regulation: 21 CFR 866.2330
Advisory panel: Microbiology
Date received: 1987-08-18
Decision date: 1987-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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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.