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FDA 510(k)

HEMATOLOGY CALIBRATOR S-CAL

K-Number: K813375 · 1982-02-04

ApplicantCoulter Electronics, Inc.
Decision Date1982-02-04
Product CodeKSA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY CALIBRATOR S-CAL is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K813375. 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 HEMATOLOGY CALIBRATOR S-CAL?

HEMATOLOGY CALIBRATOR S-CAL is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K813375.

When did HEMATOLOGY CALIBRATOR S-CAL receive FDA 510(k) clearance?

HEMATOLOGY CALIBRATOR S-CAL received FDA 510(k) clearance on 1982-02-04, under 510(k) number K813375.

Who is the listed applicant for HEMATOLOGY CALIBRATOR S-CAL?

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

What is the FDA product code for HEMATOLOGY CALIBRATOR S-CAL?

The FDA product code for HEMATOLOGY CALIBRATOR S-CAL is KSA.

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Other records listing Coulter Electronics, Inc. as applicant

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K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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