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FDA 510(k)

CELL-CHEX WITH CPPD CRYSTALS

K-Number: K110718 · 2011-05-26

ApplicantStreck
Decision Date2011-05-26
Product CodeGLQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-CHEX WITH CPPD CRYSTALS is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2011-05-26 under 510(k) number K110718. The device is classified under product code GLQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELL-CHEX WITH CPPD CRYSTALS?

CELL-CHEX WITH CPPD CRYSTALS is a medical device that received FDA 510(k) clearance on 2011-05-26. The listed applicant is Streck. The 510(k) number is K110718.

When did CELL-CHEX WITH CPPD CRYSTALS receive FDA 510(k) clearance?

CELL-CHEX WITH CPPD CRYSTALS received FDA 510(k) clearance on 2011-05-26, under 510(k) number K110718.

Who is the listed applicant for CELL-CHEX WITH CPPD CRYSTALS?

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 WITH CPPD CRYSTALS?

The FDA product code for CELL-CHEX WITH CPPD CRYSTALS is GLQ.

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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: GLQ)

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.

K111211CELL-DYN 22 PLUS CONTROLStreckK101335CELL-CHEXStreckK090137STAK-CHEX PLUS RETICSStreckK000945PARA 12 PLUS RETICSStreck Laboratories, Inc.K994388XE CHECKStreck Laboratories, Inc.K992887STAK-CHEX PLUS RETICSStreck Laboratories, 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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