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FDA 510(k)

ACA ANTITHROMBIN III PLASMINOGEN CALIB

K-Number: K812626 · 1981-11-24

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1981-11-24
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACA ANTITHROMBIN III PLASMINOGEN CALIB 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 1981-11-24 under 510(k) number K812626. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA ANTITHROMBIN III PLASMINOGEN CALIB?

ACA ANTITHROMBIN III PLASMINOGEN CALIB is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K812626.

When did ACA ANTITHROMBIN III PLASMINOGEN CALIB receive FDA 510(k) clearance?

ACA ANTITHROMBIN III PLASMINOGEN CALIB received FDA 510(k) clearance on 1981-11-24, under 510(k) number K812626.

Who is the listed applicant for ACA ANTITHROMBIN III PLASMINOGEN CALIB?

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 ANTITHROMBIN III PLASMINOGEN CALIB?

The FDA product code for ACA ANTITHROMBIN III PLASMINOGEN CALIB is JBQ.

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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: JBQ)

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.

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbHK081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare DiagnosticsK070301HEMOSIL ANTITHROMBINInstrumentation Laboratory COK062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory COK043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen BiomedK033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation Laboratory CO

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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