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FDA 510(k)

ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES

K-Number: K853198 · 1985-10-04

ApplicantMedical Device Consultants, Inc.
Decision Date1985-10-04
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Consultants, Inc.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853198. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES?

ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Medical Device Consultants, Inc.. The 510(k) number is K853198.

When did ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES receive FDA 510(k) clearance?

ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853198.

Who is the listed applicant for ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES?

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

What is the FDA product code for ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES?

The FDA product code for ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES is JPA.

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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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