FDA 510(k)

UNI-PLATE

K-Number: K852643 · 1985-08-08

ApplicantMedical Specialties Laboratories

Decision Date1985-08-08

Product Code

DecisionSubstantially Equivalent

Device Summary

UNI-PLATE 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 1985-08-08 under 510(k) number K852643. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-PLATE?

UNI-PLATE is a medical device that received FDA 510(k) clearance on 1985-08-08. The listed applicant is Medical Specialties Laboratories. The 510(k) number is K852643.

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

UNI-PLATE received FDA 510(k) clearance on 1985-08-08, under 510(k) number K852643.

Who is the listed applicant for UNI-PLATE?

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

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Specialties Laboratories as applicant

K844897HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 K840114COAGULATION FACTOR DEFICIENT PLASMA K823587UNI-CELL K810268NORMLCERA

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.