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)

HY-PREP SYSTEM

K-Number: K913809 · 1992-01-15

ApplicantHyperion, Inc.
Decision Date1992-01-15
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HY-PREP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hyperion, Inc.. It received FDA 510(k) clearance on 1992-01-15 under 510(k) number K913809. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HY-PREP SYSTEM?

HY-PREP SYSTEM is a medical device that received FDA 510(k) clearance on 1992-01-15. The listed applicant is Hyperion, Inc.. The 510(k) number is K913809.

When did HY-PREP SYSTEM receive FDA 510(k) clearance?

HY-PREP SYSTEM received FDA 510(k) clearance on 1992-01-15, under 510(k) number K913809.

Who is the listed applicant for HY-PREP SYSTEM?

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

What is the FDA product code for HY-PREP SYSTEM?

The FDA product code for HY-PREP SYSTEM is JQW.

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 Hyperion, 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.

K022800VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEMK013213HYPERION VISIQUANT ANA TEST KITK935983MICROREADER 4K873138MICRO-READER IIK864060MICRO-READERK855149COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER

View all 8 devices →

Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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.

↑