DeviceClearance

IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material— 510(k) K143373

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K143373 for IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material, Substantially Equivalent on 2015-02-26. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code JJX
Device class
Class 1
Regulation
21 CFR 862.1660
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Los Angeles, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JJX

product code JJX
Other
2
Total
2

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 →

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