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)

RESOLVE-CSF

K-Number: K843122 · 1984-11-30

ApplicantIsolab, Inc.
Decision Date1984-11-30
Product CodeDFI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RESOLVE-CSF is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1984-11-30 under 510(k) number K843122. The device is classified under product code DFI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOLVE-CSF?

RESOLVE-CSF is a medical device that received FDA 510(k) clearance on 1984-11-30. The listed applicant is Isolab, Inc.. The 510(k) number is K843122.

When did RESOLVE-CSF receive FDA 510(k) clearance?

RESOLVE-CSF received FDA 510(k) clearance on 1984-11-30, under 510(k) number K843122.

Who is the listed applicant for RESOLVE-CSF?

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

What is the FDA product code for RESOLVE-CSF?

The FDA product code for RESOLVE-CSF is DFI.

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 Isolab, 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.

K951014ISOLAB'S T4 TEST KITK950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITK943547PHENYLALANINE TEST KITK950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEK950415FLUOROSCAN NEONATALK942276QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY

View all 44 devices →

Related Devices (Code: DFI)

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.

K854190CANTROL SPINAL FLUID CONTROLCanyon Diagnostics, Inc.K840974SOMAS HUMAN SPINAL FLUID CONTROLSomas Medical Industries, Inc.K832821FIAX IGG TESTIntl. Diagnostic Technology

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.

↑