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FDA 510(k)

ORTHO HEMATOLOGY CONTROL

K-Number: K803073 · 1980-12-31

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

Device Summary

ORTHO HEMATOLOGY CONTROL 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 K803073. 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?

ORTHO HEMATOLOGY CONTROL 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 K803073.

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

ORTHO HEMATOLOGY CONTROL received FDA 510(k) clearance on 1980-12-31, under 510(k) number K803073.

Who is the listed applicant for ORTHO HEMATOLOGY CONTROL?

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?

The FDA product code for ORTHO HEMATOLOGY CONTROL is JPK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-NORMALK803084ORTHO HEMATOLOGY CONTROL ABNORMAL LOWK802094ORTHO 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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