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FDA 510(k)

S-CAL HEMATOLOGY CALIBRATOR

K-Number: K862122 · 1987-05-20

ApplicantCoulter Electronics, Inc.
Decision Date1987-05-20
Product CodeKRY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

S-CAL HEMATOLOGY CALIBRATOR 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 1987-05-20 under 510(k) number K862122. The device is classified under product code KRY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-CAL HEMATOLOGY CALIBRATOR?

S-CAL HEMATOLOGY CALIBRATOR is a medical device that received FDA 510(k) clearance on 1987-05-20. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K862122.

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

S-CAL HEMATOLOGY CALIBRATOR received FDA 510(k) clearance on 1987-05-20, under 510(k) number K862122.

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

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 S-CAL HEMATOLOGY CALIBRATOR?

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

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Other records listing Coulter Electronics, 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.

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

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Related Devices (Code: KRY)

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.

K852016LASER PLATELETCAL/MULTIPLER&D Systems, Inc.K843910COULTER MEAN PLATELET VOLUME CALIBRATORCoulter Electronics, Inc.K840794S-CAL HEMATOLOGY CALIBRATORCoulter Electronics, Inc.K821851CONTROL DIAGNOSTICS PLATELET CONTROLImmunogeneticsK781601TEKNI-CALStreck Laboratories, Inc.K781133PC-CALIBRATORStreck 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.

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