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FDA 510(k)

AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)

K-Number: K030340 · 2003-04-11

ApplicantCytomedix
Decision Date2003-04-11
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) is the device name listed in this FDA 510(k) record. The listed applicant is Cytomedix. It received FDA 510(k) clearance on 2003-04-11 under 510(k) number K030340. The device is classified under product code JQC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)?

AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) is a medical device that received FDA 510(k) clearance on 2003-04-11. The listed applicant is Cytomedix. The 510(k) number is K030340.

When did AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) receive FDA 510(k) clearance?

AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) received FDA 510(k) clearance on 2003-04-11, under 510(k) number K030340.

Who is the listed applicant for AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)?

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

What is the FDA product code for AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)?

The FDA product code for AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) is JQC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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