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FDA 510(k)

DADE HEPZYME

K-Number: K925452 · 1993-01-11

ApplicantBaxter Diagnostics, Inc.
Decision Date1993-01-11
Product CodeJBR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE HEPZYME 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 1993-01-11 under 510(k) number K925452. The device is classified under product code JBR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE HEPZYME?

DADE HEPZYME is a medical device that received FDA 510(k) clearance on 1993-01-11. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K925452.

When did DADE HEPZYME receive FDA 510(k) clearance?

DADE HEPZYME received FDA 510(k) clearance on 1993-01-11, under 510(k) number K925452.

Who is the listed applicant for DADE HEPZYME?

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 HEPZYME?

The FDA product code for DADE HEPZYME is JBR.

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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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