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FDA 510(k)

ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK

K-Number: K852520 · 1985-10-04

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1985-10-04
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK 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 1985-10-04 under 510(k) number K852520. The device is classified under product code GHH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK?

ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K852520.

When did ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK receive FDA 510(k) clearance?

ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK received FDA 510(k) clearance on 1985-10-04, under 510(k) number K852520.

Who is the listed applicant for ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK?

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 FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK?

The FDA product code for ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK is GHH.

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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.

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Related Devices (Code: GHH)

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.

K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme LaboratoriesK072288PATHFAST D-DIMERMitsubishi Kagaku IatronK070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLOlympus Life & Material Science Europa GmbH (IrishK062203TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K042890TRIAGE D-DIMER TEST, MODEL 98100Biosite IncorporatedK030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.

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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