CARIESCREEN - SM— 510(k) K852987

Name: FDA 510(k) clearance K852987
Creator: U.S. Food and Drug Administration
Published: 1985-08-19

Substantially Equivalent

Pharma-Medica of Scandinavia, Ltd.

FDA 510(k) clearance K852987 for CARIESCREEN - SM, Substantially Equivalent on 1985-08-19. Applicant: Pharma-Medica of Scandinavia, Ltd.. Device class: 1.

Clearance details

Applicant: Pharma-Medica of Scandinavia, Ltd.
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1985-07-15
Decision date: 1985-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario L3r 2s2 Canada, CA

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.