FDA 510(k)

CELL-CHEX

K-Number: K101335 · 2010-08-23

ApplicantStreck

Decision Date2010-08-23

Product CodeGLQ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CELL-CHEX is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2010-08-23 under 510(k) number K101335. 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?

CELL-CHEX is a medical device that received FDA 510(k) clearance on 2010-08-23. The listed applicant is Streck. The 510(k) number is K101335.

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

CELL-CHEX received FDA 510(k) clearance on 2010-08-23, under 510(k) number K101335.

Who is the listed applicant for CELL-CHEX?

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?

The FDA product code for CELL-CHEX is GLQ.

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: GLQ)

K111211CELL-DYN 22 PLUS CONTROLStreck K110718CELL-CHEX WITH CPPD CRYSTALSStreck K090137STAK-CHEX PLUS RETICSStreck K000945PARA 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.