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FDA 510(k)

ACA PROTHROMBIN TIME ANALYTICAL TEST PACK

K-Number: K851125 · 1985-05-29

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1985-05-29
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACA PROTHROMBIN TIME 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 1985-05-29 under 510(k) number K851125. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA PROTHROMBIN TIME ANALYTICAL TEST PACK?

ACA PROTHROMBIN TIME ANALYTICAL TEST PACK is a medical device that received FDA 510(k) clearance on 1985-05-29. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K851125.

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

ACA PROTHROMBIN TIME ANALYTICAL TEST PACK received FDA 510(k) clearance on 1985-05-29, under 510(k) number K851125.

Who is the listed applicant for ACA PROTHROMBIN TIME 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 PROTHROMBIN TIME ANALYTICAL TEST PACK?

The FDA product code for ACA PROTHROMBIN TIME ANALYTICAL TEST PACK is GJS.

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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: GJS)

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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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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