FDA 510(k)

CELL-CHEX AUTO

K-Number: K053362 · 2006-01-13

ApplicantStreck

Decision Date2006-01-13

Product CodeJPK

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CELL-CHEX AUTO is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2006-01-13 under 510(k) number K053362. 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 CELL-CHEX AUTO?

CELL-CHEX AUTO is a medical device that received FDA 510(k) clearance on 2006-01-13. The listed applicant is Streck. The 510(k) number is K053362.

When did CELL-CHEX AUTO receive FDA 510(k) clearance?

CELL-CHEX AUTO received FDA 510(k) clearance on 2006-01-13, under 510(k) number K053362.

Who is the listed applicant for CELL-CHEX AUTO?

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-CHEX AUTO?

The FDA product code for CELL-CHEX AUTO is JPK.

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: JPK)

K160586XN-L CHECKStreck K160590XN CHECKStreck K160588XN CHECK BFStreck K160606BC-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.