FDA 510(k)

X-CAL

K-Number: K083200 · 2009-02-03

ApplicantStreck

Decision Date2009-02-03

Product CodeKRX

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

X-CAL is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2009-02-03 under 510(k) number K083200. 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 X-CAL?

X-CAL is a medical device that received FDA 510(k) clearance on 2009-02-03. The listed applicant is Streck. The 510(k) number is K083200.

When did X-CAL receive FDA 510(k) clearance?

X-CAL received FDA 510(k) clearance on 2009-02-03, under 510(k) number K083200.

Who is the listed applicant for X-CAL?

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 X-CAL?

The FDA product code for X-CAL 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 K120747XN CAL PFStreck K120745XN CALStreck K111204CELL-DYN 22 PLUS CALIBRATORStreck 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.