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FDA 510(k)

CAPILLARY'S IMMUNOTYPING (PN 2100)

K-Number: K042939 · 2005-06-27

ApplicantSebia, Inc.
Decision Date2005-06-27
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CAPILLARY'S IMMUNOTYPING (PN 2100) is the device name listed in this FDA 510(k) record. The listed applicant is Sebia, Inc.. It received FDA 510(k) clearance on 2005-06-27 under 510(k) number K042939. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPILLARY'S IMMUNOTYPING (PN 2100)?

CAPILLARY'S IMMUNOTYPING (PN 2100) is a medical device that received FDA 510(k) clearance on 2005-06-27. The listed applicant is Sebia, Inc.. The 510(k) number is K042939.

When did CAPILLARY'S IMMUNOTYPING (PN 2100) receive FDA 510(k) clearance?

CAPILLARY'S IMMUNOTYPING (PN 2100) received FDA 510(k) clearance on 2005-06-27, under 510(k) number K042939.

Who is the listed applicant for CAPILLARY'S IMMUNOTYPING (PN 2100)?

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

What is the FDA product code for CAPILLARY'S IMMUNOTYPING (PN 2100)?

The FDA product code for CAPILLARY'S IMMUNOTYPING (PN 2100) is DFH.

Related Clinical Trials

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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Other records listing Sebia, 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.

K070486CAPILLARYS URINE (PN 2012)

Related Devices (Code: DFH)

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.

K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDiazyme Laboratories, Inc.K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2SebiaK231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2SebiaK211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.

Official Source

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