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FDA 510(k)

QUANTICEL HHR, L531 AND L532

K-Number: K781745 · 1978-11-15

ApplicantBhp Diagnostix, Inc.
Decision Date1978-11-15
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUANTICEL HHR, L531 AND L532 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 1978-11-15 under 510(k) number K781745. 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, L531 AND L532?

QUANTICEL HHR, L531 AND L532 is a medical device that received FDA 510(k) clearance on 1978-11-15. The listed applicant is Bhp Diagnostix, Inc.. The 510(k) number is K781745.

When did QUANTICEL HHR, L531 AND L532 receive FDA 510(k) clearance?

QUANTICEL HHR, L531 AND L532 received FDA 510(k) clearance on 1978-11-15, under 510(k) number K781745.

Who is the listed applicant for QUANTICEL HHR, L531 AND L532?

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, L531 AND L532?

The FDA product code for QUANTICEL HHR, L531 AND L532 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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