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FDA 510(k)

HEPARIN ACA ANALYTICAL TEST PACK

K-Number: K843201 · 1984-11-30

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1984-11-30
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEPARIN ACA 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 1984-11-30 under 510(k) number K843201. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPARIN ACA ANALYTICAL TEST PACK?

HEPARIN ACA ANALYTICAL TEST PACK is a medical device that received FDA 510(k) clearance on 1984-11-30. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K843201.

When did HEPARIN ACA ANALYTICAL TEST PACK receive FDA 510(k) clearance?

HEPARIN ACA ANALYTICAL TEST PACK received FDA 510(k) clearance on 1984-11-30, under 510(k) number K843201.

Who is the listed applicant for HEPARIN ACA 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 HEPARIN ACA ANALYTICAL TEST PACK?

The FDA product code for HEPARIN ACA ANALYTICAL TEST PACK is KFF.

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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: KFF)

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.

K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.K213464HemosIL Liquid Anti-XaInstrumentation Laboratory COK162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbHK111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory COK050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen Biomed

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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