PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH— 510(k) K973676

Substantially Equivalent

Sorrento Biochemical, Inc.

FDA 510(k) clearance K973676 for PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH, Substantially Equivalent on 1997-12-16. Applicant: Sorrento Biochemical, Inc..

Clearance details

Applicant: Sorrento Biochemical, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1997-09-26
Decision date: 1997-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.