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FDA 510(k)

COAGULATION CONTROL, LEVEL III

K-Number: K870687 · 1987-04-20

ApplicantU. S. Diagnostics, Inc.
Decision Date1987-04-20
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGULATION CONTROL, LEVEL III is the device name listed in this FDA 510(k) record. The listed applicant is U. S. Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-04-20 under 510(k) number K870687. 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 COAGULATION CONTROL, LEVEL III?

COAGULATION CONTROL, LEVEL III is a medical device that received FDA 510(k) clearance on 1987-04-20. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K870687.

When did COAGULATION CONTROL, LEVEL III receive FDA 510(k) clearance?

COAGULATION CONTROL, LEVEL III received FDA 510(k) clearance on 1987-04-20, under 510(k) number K870687.

Who is the listed applicant for COAGULATION CONTROL, LEVEL III?

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

What is the FDA product code for COAGULATION CONTROL, LEVEL III?

The FDA product code for COAGULATION CONTROL, LEVEL III 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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