CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013— 510(k) K022725

Substantially Equivalent

Good Biotech Corp.

FDA 510(k) clearance K022725 for CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013, Substantially Equivalent on 2002-09-23. Applicant: Good Biotech Corp..

Clearance details

Applicant: Good Biotech Corp.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2002-08-16
Decision date: 2002-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

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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.