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FDA 510(k)

CELL-DYN 22 PLUS CALIBRATOR

K-Number: K111204 · 2011-12-22

ApplicantStreck
Decision Date2011-12-22
Product CodeKRX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN 22 PLUS CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K111204. 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 CELL-DYN 22 PLUS CALIBRATOR?

CELL-DYN 22 PLUS CALIBRATOR is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Streck. The 510(k) number is K111204.

When did CELL-DYN 22 PLUS CALIBRATOR receive FDA 510(k) clearance?

CELL-DYN 22 PLUS CALIBRATOR received FDA 510(k) clearance on 2011-12-22, under 510(k) number K111204.

Who is the listed applicant for CELL-DYN 22 PLUS CALIBRATOR?

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 CELL-DYN 22 PLUS CALIBRATOR?

The FDA product code for CELL-DYN 22 PLUS CALIBRATOR is KRX.

Related Clinical Trials

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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 BCNK231221MDx-Chex for BC-GPK231223MDx-Chex for BC-GNK170091UA-Cellular CompleteK160585XN CALK160590XN CHECK

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Related Devices (Code: KRX)

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.

K160585XN CALStreckK120747XN CAL PFStreckK120745XN CALStreckK083200X-CALStreckK020469CAL-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.

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