FDA 510(k)

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA

K-Number: K920895 · 1992-06-04

Decision Date1992-06-04

Product CodeMIF

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-06-04 under 510(k) number K920895. The device is classified under product code MIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA?

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA is a medical device that received FDA 510(k) clearance on 1992-06-04. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K920895.

When did DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA receive FDA 510(k) clearance?

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA received FDA 510(k) clearance on 1992-06-04, under 510(k) number K920895.

Who is the listed applicant for DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA?

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

What is the FDA product code for DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA?

The FDA product code for DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA is MIF.

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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.