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FDA 510(k)

HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8

K-Number: K844897 · 1985-03-22

ApplicantMedical Specialties Laboratories
Decision Date1985-03-22
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties Laboratories. It received FDA 510(k) clearance on 1985-03-22 under 510(k) number K844897. 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 HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8?

HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 is a medical device that received FDA 510(k) clearance on 1985-03-22. The listed applicant is Medical Specialties Laboratories. The 510(k) number is K844897.

When did HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 receive FDA 510(k) clearance?

HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 received FDA 510(k) clearance on 1985-03-22, under 510(k) number K844897.

Who is the listed applicant for HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8?

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

What is the FDA product code for HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8?

The FDA product code for HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 is JPK.

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Other records listing Medical Specialties Laboratories 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.

K852643UNI-PLATEK840114COAGULATION FACTOR DEFICIENT PLASMAK823587UNI-CELLK810268NORMLCERA

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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