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FDA 510(k)

QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS

K-Number: K844927 · 1985-03-22

ApplicantBhp Diagnostix, Inc.
Decision Date1985-03-22
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS is the device name listed in this FDA 510(k) record. The listed applicant is Bhp Diagnostix, Inc.. It received FDA 510(k) clearance on 1985-03-22 under 510(k) number K844927. 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 QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS?

QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS is a medical device that received FDA 510(k) clearance on 1985-03-22. The listed applicant is Bhp Diagnostix, Inc.. The 510(k) number is K844927.

When did QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS receive FDA 510(k) clearance?

QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS received FDA 510(k) clearance on 1985-03-22, under 510(k) number K844927.

Who is the listed applicant for QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS?

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

What is the FDA product code for QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS?

The FDA product code for QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS is JPK.

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Other records listing Bhp Diagnostix, 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.

K904503SERACON CR REFERENCEK863648SERACON CT REFERENCEK862594SERACON(TM) CAL (PRODUCT NO. DO35)K844928QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCEK844027SERACON TM SR IIIK844026SERACON TM SR IV

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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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