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FDA 510(k)

ACA IMMUNOGLOBULIN G ANALYTICAL TEST

K-Number: K812664 · 1981-10-02

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1981-10-02
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACA IMMUNOGLOBULIN G ANALYTICAL TEST is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812664. 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 ACA IMMUNOGLOBULIN G ANALYTICAL TEST?

ACA IMMUNOGLOBULIN G ANALYTICAL TEST is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K812664.

When did ACA IMMUNOGLOBULIN G ANALYTICAL TEST receive FDA 510(k) clearance?

ACA IMMUNOGLOBULIN G ANALYTICAL TEST received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812664.

Who is the listed applicant for ACA IMMUNOGLOBULIN G ANALYTICAL TEST?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACA IMMUNOGLOBULIN G ANALYTICAL TEST?

The FDA product code for ACA IMMUNOGLOBULIN G ANALYTICAL TEST is DEW.

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Other records listing E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

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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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