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FDA 510(k)

HEMOTOLOGY CALIBRATOR

K-Number: K813530 · 1982-02-22

ApplicantAmerican Dade
Decision Date1982-02-22
Product CodeKSA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOTOLOGY CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1982-02-22 under 510(k) number K813530. The device is classified under product code KSA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOTOLOGY CALIBRATOR?

HEMOTOLOGY CALIBRATOR is a medical device that received FDA 510(k) clearance on 1982-02-22. The listed applicant is American Dade. The 510(k) number is K813530.

When did HEMOTOLOGY CALIBRATOR receive FDA 510(k) clearance?

HEMOTOLOGY CALIBRATOR received FDA 510(k) clearance on 1982-02-22, under 510(k) number K813530.

Who is the listed applicant for HEMOTOLOGY CALIBRATOR?

The FDA 510(k) record lists American Dade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOTOLOGY CALIBRATOR?

The FDA product code for HEMOTOLOGY CALIBRATOR is KSA.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

View all 149 devices →

Related Devices (Code: KSA)

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.

K943268SCS-1000 (SYSMEX CALIBRATOR SYSTEM)Streck Laboratories, Inc.K897060CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLER&D Systems, Inc.K881161TECH-CAL(TM)/MULTIPLER&D Systems, Inc.K864664H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORSTechnicon Instruments Corp.K854823CBC-CAL/MULTIPLER&D Systems, Inc.K844708TRI-COUNT CALIBRATORHematology Marketing Assoc.

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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