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FDA 510(k)

COULTER CHECK SAMPLE UNASSAYED HEMATOLOG

K-Number: K843805 · 1984-12-17

ApplicantCoulter Electronics, Inc.
Decision Date1984-12-17
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER CHECK SAMPLE UNASSAYED HEMATOLOG 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 1984-12-17 under 510(k) number K843805. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER CHECK SAMPLE UNASSAYED HEMATOLOG?

COULTER CHECK SAMPLE UNASSAYED HEMATOLOG is a medical device that received FDA 510(k) clearance on 1984-12-17. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K843805.

When did COULTER CHECK SAMPLE UNASSAYED HEMATOLOG receive FDA 510(k) clearance?

COULTER CHECK SAMPLE UNASSAYED HEMATOLOG received FDA 510(k) clearance on 1984-12-17, under 510(k) number K843805.

Who is the listed applicant for COULTER CHECK SAMPLE UNASSAYED HEMATOLOG?

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 COULTER CHECK SAMPLE UNASSAYED HEMATOLOG?

The FDA product code for COULTER CHECK SAMPLE UNASSAYED HEMATOLOG is JPK.

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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: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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