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FDA 510(k)

NORMAL HEMATOLOGY CONTROL UNASSAYED

K-Number: K781572 · 1978-10-17

ApplicantOrtho Diagnostics, Inc.
Decision Date1978-10-17
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NORMAL HEMATOLOGY CONTROL UNASSAYED is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostics, Inc.. It received FDA 510(k) clearance on 1978-10-17 under 510(k) number K781572. 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 NORMAL HEMATOLOGY CONTROL UNASSAYED?

NORMAL HEMATOLOGY CONTROL UNASSAYED is a medical device that received FDA 510(k) clearance on 1978-10-17. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K781572.

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

NORMAL HEMATOLOGY CONTROL UNASSAYED received FDA 510(k) clearance on 1978-10-17, under 510(k) number K781572.

Who is the listed applicant for NORMAL HEMATOLOGY CONTROL UNASSAYED?

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

What is the FDA product code for NORMAL HEMATOLOGY CONTROL UNASSAYED?

The FDA product code for NORMAL HEMATOLOGY CONTROL UNASSAYED is JPK.

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Other records listing Ortho Diagnostics, Inc. as applicant

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K802404ORTHO BOVINE ALBUMIN SOLUTION 30% PROTEK801507ANTIGEN CONTROL CELLSK800357BI-LEVEL ASSAYED CARD. DRUG CONT., I,IIK800310ORTHO ANTISERA CONTROLK791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONK791301ORTHO TSH RIA KIT

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Related Devices (Code: JPK)

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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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