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FDA 510(k)

DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR

K-Number: K852176 · 1985-08-12

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1985-08-12
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS 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 1985-08-12 under 510(k) number K852176. 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 DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR?

DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR is a medical device that received FDA 510(k) clearance on 1985-08-12. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K852176.

When did DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR receive FDA 510(k) clearance?

DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR received FDA 510(k) clearance on 1985-08-12, under 510(k) number K852176.

Who is the listed applicant for DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS 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 DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR?

The FDA product code for DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR 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.

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: 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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