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FDA 510(k)

QUANTICEL-HRP

K-Number: K781247 · 1978-09-14

ApplicantBhp Diagnostix, Inc.
Decision Date1978-09-14
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUANTICEL-HRP 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 1978-09-14 under 510(k) number K781247. 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-HRP?

QUANTICEL-HRP is a medical device that received FDA 510(k) clearance on 1978-09-14. The listed applicant is Bhp Diagnostix, Inc.. The 510(k) number is K781247.

When did QUANTICEL-HRP receive FDA 510(k) clearance?

QUANTICEL-HRP received FDA 510(k) clearance on 1978-09-14, under 510(k) number K781247.

Who is the listed applicant for QUANTICEL-HRP?

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-HRP?

The FDA product code for QUANTICEL-HRP 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 REFERENCEK844927QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETSK844027SERACON TM SR III

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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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