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FDA 510(k)

THE DPC MONOCLONAL EIA TOTAL IGE KIT

K-Number: K852878 · 1985-08-28

ApplicantDiagnostic Products Corp.
Decision Date1985-08-28
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THE DPC MONOCLONAL EIA TOTAL IGE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1985-08-28 under 510(k) number K852878. 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 THE DPC MONOCLONAL EIA TOTAL IGE KIT?

THE DPC MONOCLONAL EIA TOTAL IGE KIT is a medical device that received FDA 510(k) clearance on 1985-08-28. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K852878.

When did THE DPC MONOCLONAL EIA TOTAL IGE KIT receive FDA 510(k) clearance?

THE DPC MONOCLONAL EIA TOTAL IGE KIT received FDA 510(k) clearance on 1985-08-28, under 510(k) number K852878.

Who is the listed applicant for THE DPC MONOCLONAL EIA TOTAL IGE KIT?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE DPC MONOCLONAL EIA TOTAL IGE KIT?

The FDA product code for THE DPC MONOCLONAL EIA TOTAL IGE KIT is DGC.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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Related Devices (Code: DGC)

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.

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 ABK063425DIMENSION 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.

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