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FDA 510(k)

DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR

K-Number: K922698 · 1992-09-09

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1992-09-09
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR 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 1992-09-09 under 510(k) number K922698. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR?

DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR is a medical device that received FDA 510(k) clearance on 1992-09-09. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K922698.

When did DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR receive FDA 510(k) clearance?

DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR received FDA 510(k) clearance on 1992-09-09, under 510(k) number K922698.

Who is the listed applicant for DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR?

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 DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR?

The FDA product code for DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR is JIS.

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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: JIS)

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.

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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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