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FDA 510(k)

RED BLOOD CELL COUNT & HEMATOCRIT CNTL

K-Number: K801267 · 1980-07-14

ApplicantBioscientific
Decision Date1980-07-14
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RED BLOOD CELL COUNT & HEMATOCRIT CNTL is the device name listed in this FDA 510(k) record. The listed applicant is Bioscientific. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801267. 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 RED BLOOD CELL COUNT & HEMATOCRIT CNTL?

RED BLOOD CELL COUNT & HEMATOCRIT CNTL is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Bioscientific. The 510(k) number is K801267.

When did RED BLOOD CELL COUNT & HEMATOCRIT CNTL receive FDA 510(k) clearance?

RED BLOOD CELL COUNT & HEMATOCRIT CNTL received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801267.

Who is the listed applicant for RED BLOOD CELL COUNT & HEMATOCRIT CNTL?

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

What is the FDA product code for RED BLOOD CELL COUNT & HEMATOCRIT CNTL?

The FDA product code for RED BLOOD CELL COUNT & HEMATOCRIT CNTL is JPK.

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Other records listing Bioscientific 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.

K812447AMYLASE REAGENT KITK811251CITRATE BUFFERK801265WHITE BLOOD CELL COUNT CONTROL LEVELSK801268HEMOGLOBIN CONTROL LEVELSK791658WRIGHT STAIN PACKK791007STAT DIFF STAIN

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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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