HCG CONTROL— 510(k) K921206

Substantially Equivalent

Polymedco, Inc.

FDA 510(k) clearance K921206 for HCG CONTROL, Substantially Equivalent on 1992-04-29. Applicant: Polymedco, Inc..

Clearance details

Applicant: Polymedco, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1992-03-13
Decision date: 1992-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.