FDA 510(k)

CBC-SF

K-Number: K010409 · 2001-03-16

Decision Date2001-03-16

Product CodeJPK

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CBC-SF 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 2001-03-16 under 510(k) number K010409. 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 CBC-SF?

CBC-SF is a medical device that received FDA 510(k) clearance on 2001-03-16. The listed applicant is R&D Systems, Inc.. The 510(k) number is K010409.

When did CBC-SF receive FDA 510(k) clearance?

CBC-SF received FDA 510(k) clearance on 2001-03-16, under 510(k) number K010409.

Who is the listed applicant for CBC-SF?

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 CBC-SF?

The FDA product code for CBC-SF is JPK.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.