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FDA 510(k)

HEMOTOLOGY QUALITY CONTROL MIXTURES

K-Number: K810756 · 1981-06-30

ApplicantScientific Standards, Inc.
Decision Date1981-06-30
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOTOLOGY QUALITY CONTROL MIXTURES is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Standards, Inc.. It received FDA 510(k) clearance on 1981-06-30 under 510(k) number K810756. 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 HEMOTOLOGY QUALITY CONTROL MIXTURES?

HEMOTOLOGY QUALITY CONTROL MIXTURES is a medical device that received FDA 510(k) clearance on 1981-06-30. The listed applicant is Scientific Standards, Inc.. The 510(k) number is K810756.

When did HEMOTOLOGY QUALITY CONTROL MIXTURES receive FDA 510(k) clearance?

HEMOTOLOGY QUALITY CONTROL MIXTURES received FDA 510(k) clearance on 1981-06-30, under 510(k) number K810756.

Who is the listed applicant for HEMOTOLOGY QUALITY CONTROL MIXTURES?

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

What is the FDA product code for HEMOTOLOGY QUALITY CONTROL MIXTURES?

The FDA product code for HEMOTOLOGY QUALITY CONTROL MIXTURES is JPK.

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Other records listing Scientific Standards, 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.

K800938TRI-CHECK

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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