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FDA 510(k)

TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN

K-Number: K833402 · 1984-01-24

ApplicantTechnicon Instruments Corp.
Decision Date1984-01-24
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1984-01-24 under 510(k) number K833402. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN?

TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN is a medical device that received FDA 510(k) clearance on 1984-01-24. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K833402.

When did TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN receive FDA 510(k) clearance?

TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN received FDA 510(k) clearance on 1984-01-24, under 510(k) number K833402.

Who is the listed applicant for TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN?

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

What is the FDA product code for TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN?

The FDA product code for TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN is DEW.

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Related Devices (Code: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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