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FDA 510(k)

CAL-CHEX, A HEMATOLOGY CALIBRATOR

K-Number: K840261 · 1984-02-21

ApplicantStreck Laboratories, Inc.
Decision Date1984-02-21
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CAL-CHEX, A HEMATOLOGY CALIBRATOR 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 1984-02-21 under 510(k) number K840261. The device is classified under product code KRZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAL-CHEX, A HEMATOLOGY CALIBRATOR?

CAL-CHEX, A HEMATOLOGY CALIBRATOR is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K840261.

When did CAL-CHEX, A HEMATOLOGY CALIBRATOR receive FDA 510(k) clearance?

CAL-CHEX, A HEMATOLOGY CALIBRATOR received FDA 510(k) clearance on 1984-02-21, under 510(k) number K840261.

Who is the listed applicant for CAL-CHEX, A HEMATOLOGY CALIBRATOR?

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, A HEMATOLOGY CALIBRATOR?

The FDA product code for CAL-CHEX, A HEMATOLOGY CALIBRATOR is KRZ.

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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-DYNK040107CYTO-CHEX BCTK040025A1C-CELLULARK023656SICKLE-CHEX SOLUBILITY KITK021922MODIFICATION TO PARA 5XK020469CAL-CHEX CD PLUS

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Related Devices (Code: KRZ)

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.

K052101C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CRoche DiagnosticsK041130CDS HEMATOLOGY CALIBRATOR (CDS CAL)Clinical Diagnostic Solutions, Inc.K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSAlko Diagnostic Corp.K951071ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERSAlko Diagnostic Corp.K902892CELL-DYN CALIBRATORUnipath , Ltd.K896921RAICHEM TM HEMOGLOBIN CALIBRATORReagents Applications, 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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