FDA 510(k)

ACCESS(R) TOTAL IGE ASSAY

K-Number: K930984 · 1993-06-09

Decision Date1993-06-09

Product CodeDGC

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

ACCESS(R) TOTAL IGE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 1993-06-09 under 510(k) number K930984. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS(R) TOTAL IGE ASSAY?

ACCESS(R) TOTAL IGE ASSAY is a medical device that received FDA 510(k) clearance on 1993-06-09. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K930984.

When did ACCESS(R) TOTAL IGE ASSAY receive FDA 510(k) clearance?

ACCESS(R) TOTAL IGE ASSAY received FDA 510(k) clearance on 1993-06-09, under 510(k) number K930984.

Who is the listed applicant for ACCESS(R) TOTAL IGE ASSAY?

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

What is the FDA product code for ACCESS(R) TOTAL IGE ASSAY?

The FDA product code for ACCESS(R) TOTAL IGE ASSAY is DGC.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bio-Rad Laboratories, Inc. as applicant

K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software K161687D-10 Hemoglobin A1c Program K130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI K130963LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK K120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK

View all 79 devices →

Related Devices (Code: DGC)

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia AB K063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, 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.