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FDA 510(k)

TRI-COUNT

K-Number: K851375 · 1985-07-12

ApplicantHematology Marketing Assoc.
Decision Date1985-07-12
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TRI-COUNT is the device name listed in this FDA 510(k) record. The listed applicant is Hematology Marketing Assoc.. It received FDA 510(k) clearance on 1985-07-12 under 510(k) number K851375. 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 TRI-COUNT?

TRI-COUNT is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Hematology Marketing Assoc.. The 510(k) number is K851375.

When did TRI-COUNT receive FDA 510(k) clearance?

TRI-COUNT received FDA 510(k) clearance on 1985-07-12, under 510(k) number K851375.

Who is the listed applicant for TRI-COUNT?

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

What is the FDA product code for TRI-COUNT?

The FDA product code for TRI-COUNT is JPK.

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Other records listing Hematology Marketing Assoc. 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.

K851843OSMOCEL 3K850094LASER-GLOBIN POWDERK850095LASER-DILK850097LASER-LYSEK850096LASER-GLOBINK844708TRI-COUNT CALIBRATOR

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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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