FDA 510(k)

XN CAL PF

K-Number: K120747 · 2012-10-22

ApplicantStreck

Decision Date2012-10-22

Product CodeKRX

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

XN CAL PF is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2012-10-22 under 510(k) number K120747. The device is classified under product code KRX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XN CAL PF?

XN CAL PF is a medical device that received FDA 510(k) clearance on 2012-10-22. The listed applicant is Streck. The 510(k) number is K120747.

When did XN CAL PF receive FDA 510(k) clearance?

XN CAL PF received FDA 510(k) clearance on 2012-10-22, under 510(k) number K120747.

Who is the listed applicant for XN CAL PF?

The FDA 510(k) record lists Streck as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XN CAL PF?

The FDA product code for XN CAL PF is KRX.

Other records listing Streck as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254166MDx-Chex for BCN K231221MDx-Chex for BC-GP K231223MDx-Chex for BC-GN K170091UA-Cellular Complete K160585XN CAL K160590XN CHECK

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Related Devices (Code: KRX)

K160585XN CALStreck K120745XN CALStreck K111204CELL-DYN 22 PLUS CALIBRATORStreck K083200X-CALStreck K020469CAL-CHEX CD PLUSStreck Laboratories, Inc.K003991CD-CAL PLUS CALIBRATORR&D Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.