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

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..

Clearance details

Applicant
Lakewood Biochemical Co., Inc.
Product code
Code KZI
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dallas, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KZI

product code KZI
Malfunction
2,834
Total
2,834

Source: openFDA MAUDE database, through . 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.