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)

DIGILAB 350 THE KRAKAU PERIMETER

K-Number: K832175 · 1983-08-16

ApplicantBio-Rad
Decision Date1983-08-16
Product CodeHPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIGILAB 350 THE KRAKAU PERIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1983-08-16 under 510(k) number K832175. The device is classified under product code HPT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGILAB 350 THE KRAKAU PERIMETER?

DIGILAB 350 THE KRAKAU PERIMETER is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Bio-Rad. The 510(k) number is K832175.

When did DIGILAB 350 THE KRAKAU PERIMETER receive FDA 510(k) clearance?

DIGILAB 350 THE KRAKAU PERIMETER received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832175.

Who is the listed applicant for DIGILAB 350 THE KRAKAU PERIMETER?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGILAB 350 THE KRAKAU PERIMETER?

The FDA product code for DIGILAB 350 THE KRAKAU PERIMETER is HPT.

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 Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

View all 319 devices →

Related Devices (Code: HPT)

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.

K092187MAIA, MODEL 1Centervue S.P.A.K093213GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESCarl Zeiss Meditec, Inc.K091579FORESEE HOMENotal Vision , Ltd.K063310TRUEFIELD ANALYZERSeeing Machines LimitedK050350THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)Notal Vision, Inc.K023623NOVAVISION, MODEL 2.0Novavision, 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.

↑