FDA 510(k)

UNI-CELL

K-Number: K823587 · 1983-01-05

ApplicantMedical Specialties Laboratories

Decision Date1983-01-05

Product CodeGLQ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

UNI-CELL 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 1983-01-05 under 510(k) number K823587. The device is classified under product code GLQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-CELL?

UNI-CELL is a medical device that received FDA 510(k) clearance on 1983-01-05. The listed applicant is Medical Specialties Laboratories. The 510(k) number is K823587.

When did UNI-CELL receive FDA 510(k) clearance?

UNI-CELL received FDA 510(k) clearance on 1983-01-05, under 510(k) number K823587.

Who is the listed applicant for UNI-CELL?

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 UNI-CELL?

The FDA product code for UNI-CELL is GLQ.

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-PLATE K844897HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 K840114COAGULATION FACTOR DEFICIENT PLASMA K810268NORMLCERA

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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.