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FDA 510(k)

IMMUNO-TROL LOW CELLS

K-Number: K013842 · 2001-12-13

ApplicantBeckman Coulter, Inc.
Decision Date2001-12-13
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMUNO-TROL LOW CELLS is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2001-12-13 under 510(k) number K013842. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNO-TROL LOW CELLS?

IMMUNO-TROL LOW CELLS is a medical device that received FDA 510(k) clearance on 2001-12-13. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K013842.

When did IMMUNO-TROL LOW CELLS receive FDA 510(k) clearance?

IMMUNO-TROL LOW CELLS received FDA 510(k) clearance on 2001-12-13, under 510(k) number K013842.

Who is the listed applicant for IMMUNO-TROL LOW CELLS?

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

What is the FDA product code for IMMUNO-TROL LOW CELLS?

The FDA product code for IMMUNO-TROL LOW CELLS is JPK.

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Related Devices (Code: JPK)

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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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