Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIOVATION DIGITAL URINOMETER

K-Number: K790862 · 1979-06-28

ApplicantBiovation, Inc.
Decision Date1979-06-28
Product CodeJRE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOVATION DIGITAL URINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Biovation, Inc.. It received FDA 510(k) clearance on 1979-06-28 under 510(k) number K790862. The device is classified under product code JRE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOVATION DIGITAL URINOMETER?

BIOVATION DIGITAL URINOMETER is a medical device that received FDA 510(k) clearance on 1979-06-28. The listed applicant is Biovation, Inc.. The 510(k) number is K790862.

When did BIOVATION DIGITAL URINOMETER receive FDA 510(k) clearance?

BIOVATION DIGITAL URINOMETER received FDA 510(k) clearance on 1979-06-28, under 510(k) number K790862.

Who is the listed applicant for BIOVATION DIGITAL URINOMETER?

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

What is the FDA product code for BIOVATION DIGITAL URINOMETER?

The FDA product code for BIOVATION DIGITAL URINOMETER is JRE.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biovation, Inc. 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.

K925528BIOVATION K-MANAGERK923844LYRIS 100/120 LABORATORY INFORMATION SYSTEMK915071DIFFERENTIAL COUNTING BOARDK853026BIOVATION MAX DATA MANAGEMENT SYSTEMK842401CHEMISTRY CONSOLEK831830LYRIS MODULAR INFO SYSTEM

View all 11 devices →

Related Devices (Code: JRE)

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.

K954977URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)Teco DiagnosticsK941906MODEL 2730 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941903MODEL 2740 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941901MODEL 2721 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941904MODEL A300CL CLINICAL REFRACTOMETERVee Gee Scientific, Inc.K941905MODEL 3461 CLINICAL REFRACTOMETERVee Gee Scientific, Inc.

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.

↑