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)

QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL

K-Number: K820630 · 1982-06-25

ApplicantIsolab, Inc.
Decision Date1982-06-25
Product CodeJPC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K820630. The device is classified under product code JPC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL?

QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Isolab, Inc.. The 510(k) number is K820630.

When did QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL receive FDA 510(k) clearance?

QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL received FDA 510(k) clearance on 1982-06-25, under 510(k) number K820630.

Who is the listed applicant for QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL?

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 QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL?

The FDA product code for QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL is JPC.

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 NEONATALK942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS

View all 44 devices →

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.

↑