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FDA 510(k)

ACTICLOT PROTEIN S, MODEL 843L

K-Number: K012386 · 2001-09-14

ApplicantAmerican Diagnostica, Inc.
Decision Date2001-09-14
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACTICLOT PROTEIN S, MODEL 843L is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostica, Inc.. It received FDA 510(k) clearance on 2001-09-14 under 510(k) number K012386. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTICLOT PROTEIN S, MODEL 843L?

ACTICLOT PROTEIN S, MODEL 843L is a medical device that received FDA 510(k) clearance on 2001-09-14. The listed applicant is American Diagnostica, Inc.. The 510(k) number is K012386.

When did ACTICLOT PROTEIN S, MODEL 843L receive FDA 510(k) clearance?

ACTICLOT PROTEIN S, MODEL 843L received FDA 510(k) clearance on 2001-09-14, under 510(k) number K012386.

Who is the listed applicant for ACTICLOT PROTEIN S, MODEL 843L?

The FDA 510(k) record lists American Diagnostica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTICLOT PROTEIN S, MODEL 843L?

The FDA product code for ACTICLOT PROTEIN S, MODEL 843L is GGP.

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Other records listing American Diagnostica, 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.

K080069DIMERTESTK063323SPECTROLYSE PAI-1, MODEL 101201K052124ACTICLOT, MODEL 824K013637ACTICHROME HEPARIN (ANTI-FIIA)K013492IMUBIND TPA ELISA, MODEL 860K013318ACTICHROME HEPARIN (ANTI-FXA), MODEL 832

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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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