FDA 510(k)

CELL-CHEX RBC

K-Number: K811741 · 1981-09-24

Decision Date1981-09-24

Product CodeKRX

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CELL-CHEX RBC 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 1981-09-24 under 510(k) number K811741. 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 CELL-CHEX RBC?

CELL-CHEX RBC is a medical device that received FDA 510(k) clearance on 1981-09-24. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K811741.

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

CELL-CHEX RBC received FDA 510(k) clearance on 1981-09-24, under 510(k) number K811741.

Who is the listed applicant for CELL-CHEX RBC?

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 CELL-CHEX RBC?

The FDA product code for CELL-CHEX RBC 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 K020469CAL-CHEX CD PLUS

View all 70 devices →

Related Devices (Code: KRX)

K160585XN CALStreck K120747XN CAL PFStreck K120745XN CALStreck K111204CELL-DYN 22 PLUS CALIBRATORStreck K083200X-CALStreck K020469CAL-CHEX CD PLUSStreck 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.