T2570 THIO W/O IND W/O DEXTROSE— 510(k) K870800

Substantially Equivalent

Lakewood Biochemical Co., Inc.

FDA 510(k) clearance K870800 for T2570 THIO W/O IND W/O DEXTROSE, Substantially Equivalent on 1987-03-31. Applicant: Lakewood Biochemical Co., Inc.. Device class: 1.

Clearance details

Applicant
Lakewood Biochemical Co., Inc.
Product code
Code JSG
Device class
Class 1
Regulation
21 CFR 866.2300
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dallas, TX, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JSG

product code JSG
Malfunction
817
Total
817

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.