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FDA 510(k)

DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.

K-Number: K922700 · 1992-08-20

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1992-08-20
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. 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 1992-08-20 under 510(k) number K922700. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.?

DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. is a medical device that received FDA 510(k) clearance on 1992-08-20. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K922700.

When did DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. receive FDA 510(k) clearance?

DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. received FDA 510(k) clearance on 1992-08-20, under 510(k) number K922700.

Who is the listed applicant for DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.?

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 MB MCKMB METH.?

The FDA product code for DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. is JHY.

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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: JHY)

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.

K132571ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche DiagnosticsK070835OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (IrishK022757SPIFE CK KIT, MODEL 3332, 3333Helena LaboratoriesK022654MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MBRoche Diagnostics Corp.K974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, 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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