FDA 510(k)

CAL-CHEX CD PLUS

K-Number: K020469 · 2002-04-04

Decision Date2002-04-04

Product CodeKRX

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CAL-CHEX CD PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 2002-04-04 under 510(k) number K020469. 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 CAL-CHEX CD PLUS?

CAL-CHEX CD PLUS is a medical device that received FDA 510(k) clearance on 2002-04-04. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K020469.

When did CAL-CHEX CD PLUS receive FDA 510(k) clearance?

CAL-CHEX CD PLUS received FDA 510(k) clearance on 2002-04-04, under 510(k) number K020469.

Who is the listed applicant for CAL-CHEX CD PLUS?

The FDA 510(k) record lists Streck Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAL-CHEX CD PLUS?

The FDA product code for CAL-CHEX CD PLUS is KRX.

Other records listing Streck Laboratories, Inc. 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.

K042587RETIC-CHEX FOR CELL-DYN K040107CYTO-CHEX BCT K040025A1C-CELLULAR K023656SICKLE-CHEX SOLUBILITY KIT K021922MODIFICATION TO PARA 5X K013316SICKLE-CHEX

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Related Devices (Code: KRX)

K160585XN CALStreck K120747XN CAL PFStreck K120745XN CALStreck K111204CELL-DYN 22 PLUS CALIBRATORStreck K083200X-CALStreck K003991CD-CAL PLUS CALIBRATORR&D Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.