CORN MEAL AGAR W/POLYSORBATE 80— 510(k) K822994

Name: FDA 510(k) clearance K822994
Creator: U.S. Food and Drug Administration
Published: 1982-11-16

Substantially Equivalent

Granite Diagnostics, Inc.

FDA 510(k) clearance K822994 for CORN MEAL AGAR W/POLYSORBATE 80, Substantially Equivalent on 1982-11-16. Applicant: Granite Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Granite Diagnostics, Inc.
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1982-10-12
Decision date: 1982-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JSJ

product code JSJ

Malfunction: 520
Total: 520

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.