T9000 TSB 10ML— 510(k) K870593

Substantially Equivalent

Lakewood Biochemical Co., Inc.

FDA 510(k) clearance K870593 for T9000 TSB 10ML, Substantially Equivalent on 1987-03-30. Applicant: Lakewood Biochemical Co., Inc..

Clearance details

Applicant: Lakewood Biochemical Co., Inc.
Product code: Code JSG
Advisory panel: Microbiology
Date received: 1987-02-10
Decision date: 1987-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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Adverse events under product code JSG

product code JSG

Malfunction: 817
Total: 817

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.