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FDA 510(k)

ORTHO HEMATOLOGY CONTROL ABNORMAL LOW

K-Number: K803084 · 1980-12-31

ApplicantOrtho Instruments
Decision Date1980-12-31
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORTHO HEMATOLOGY CONTROL ABNORMAL LOW is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Instruments. It received FDA 510(k) clearance on 1980-12-31 under 510(k) number K803084. 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 ORTHO HEMATOLOGY CONTROL ABNORMAL LOW?

ORTHO HEMATOLOGY CONTROL ABNORMAL LOW is a medical device that received FDA 510(k) clearance on 1980-12-31. The listed applicant is Ortho Instruments. The 510(k) number is K803084.

When did ORTHO HEMATOLOGY CONTROL ABNORMAL LOW receive FDA 510(k) clearance?

ORTHO HEMATOLOGY CONTROL ABNORMAL LOW received FDA 510(k) clearance on 1980-12-31, under 510(k) number K803084.

Who is the listed applicant for ORTHO HEMATOLOGY CONTROL ABNORMAL LOW?

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

What is the FDA product code for ORTHO HEMATOLOGY CONTROL ABNORMAL LOW?

The FDA product code for ORTHO HEMATOLOGY CONTROL ABNORMAL LOW is JPK.

Related Clinical Trials

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Other records listing Ortho Instruments 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.

K803083ORTHO HEMOTOLOGY CONTROL-NORMALK803073ORTHO HEMATOLOGY CONTROLK802094ORTHO SPECTRUMK801545ORTHO AUTOMATED CELL COUNTERK781146HEMAC LASER HEMATOLOGY SYSTEM

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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