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FDA 510(k)

AUTO-FI COAGULATION INSTRUMENT

K-Number: K760594 · 1976-11-24

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1976-11-24
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTO-FI COAGULATION INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1976-11-24 under 510(k) number K760594. 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 AUTO-FI COAGULATION INSTRUMENT?

AUTO-FI COAGULATION INSTRUMENT is a medical device that received FDA 510(k) clearance on 1976-11-24. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K760594.

When did AUTO-FI COAGULATION INSTRUMENT receive FDA 510(k) clearance?

AUTO-FI COAGULATION INSTRUMENT received FDA 510(k) clearance on 1976-11-24, under 510(k) number K760594.

Who is the listed applicant for AUTO-FI COAGULATION INSTRUMENT?

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

What is the FDA product code for AUTO-FI COAGULATION INSTRUMENT?

The FDA product code for AUTO-FI COAGULATION INSTRUMENT 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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