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FDA 510(k)

ORTHO HEMOTOLOGY CONTROL-NORMAL

K-Number: K803083 · 1980-12-31

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

Device Summary

ORTHO HEMOTOLOGY CONTROL-NORMAL 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 K803083. 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 HEMOTOLOGY CONTROL-NORMAL?

ORTHO HEMOTOLOGY CONTROL-NORMAL 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 K803083.

When did ORTHO HEMOTOLOGY CONTROL-NORMAL receive FDA 510(k) clearance?

ORTHO HEMOTOLOGY CONTROL-NORMAL received FDA 510(k) clearance on 1980-12-31, under 510(k) number K803083.

Who is the listed applicant for ORTHO HEMOTOLOGY CONTROL-NORMAL?

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 HEMOTOLOGY CONTROL-NORMAL?

The FDA product code for ORTHO HEMOTOLOGY CONTROL-NORMAL 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.

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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.

K803073ORTHO HEMATOLOGY CONTROLK803084ORTHO 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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