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FDA 510(k)

XN CHECK

K-Number: K120742 · 2012-10-19

ApplicantStreck
Decision Date2012-10-19
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

XN CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2012-10-19 under 510(k) number K120742. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XN CHECK?

XN CHECK is a medical device that received FDA 510(k) clearance on 2012-10-19. The listed applicant is Streck. The 510(k) number is K120742.

When did XN CHECK receive FDA 510(k) clearance?

XN CHECK received FDA 510(k) clearance on 2012-10-19, under 510(k) number K120742.

Who is the listed applicant for XN CHECK?

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 CHECK?

The FDA product code for XN CHECK is JPK.

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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: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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