DeviceClearance

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM— 510(k) K081543

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K081543 for VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM, Substantially Equivalent on 2008-10-23. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Ortho-Clinical Diagnostics, Inc.
Product code
Code JLW
Device class
Class 2
Regulation
21 CFR 862.1690
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Rochester, NY, US
Download summary PDFView on FDA.gov ↗

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More clearances from Ortho-Clinical Diagnostics, Inc.

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Adverse events under product code JLW

product code JLW
Malfunction
885
Total
885

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K081543

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081543.

Data sourced from openFDA. This site is unofficial and independent of the FDA.