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FDA 510(k)

R&D GLU-LINE HEMATOLOGY CONTROL

K-Number: K034048 · 2004-03-10

ApplicantR&D Systems, Inc.
Decision Date2004-03-10
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

R&D GLU-LINE HEMATOLOGY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 2004-03-10 under 510(k) number K034048. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R&D GLU-LINE HEMATOLOGY CONTROL?

R&D GLU-LINE HEMATOLOGY CONTROL is a medical device that received FDA 510(k) clearance on 2004-03-10. The listed applicant is R&D Systems, Inc.. The 510(k) number is K034048.

When did R&D GLU-LINE HEMATOLOGY CONTROL receive FDA 510(k) clearance?

R&D GLU-LINE HEMATOLOGY CONTROL received FDA 510(k) clearance on 2004-03-10, under 510(k) number K034048.

Who is the listed applicant for R&D GLU-LINE HEMATOLOGY CONTROL?

The FDA 510(k) record lists R&D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R&D GLU-LINE HEMATOLOGY CONTROL?

The FDA product code for R&D GLU-LINE HEMATOLOGY CONTROL is JJX.

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Other records listing R&D Systems, Inc. as applicant

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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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