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FDA 510(k)

AXIS %CDT TURBIDIMETRIC IMMUNOASSAY

K-Number: K992502 · 1999-12-21

ApplicantAxis
Decision Date1999-12-21
Product CodeNAO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXIS %CDT TURBIDIMETRIC IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Axis. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K992502. The device is classified under product code NAO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIS %CDT TURBIDIMETRIC IMMUNOASSAY?

AXIS %CDT TURBIDIMETRIC IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Axis. The 510(k) number is K992502.

When did AXIS %CDT TURBIDIMETRIC IMMUNOASSAY receive FDA 510(k) clearance?

AXIS %CDT TURBIDIMETRIC IMMUNOASSAY received FDA 510(k) clearance on 1999-12-21, under 510(k) number K992502.

Who is the listed applicant for AXIS %CDT TURBIDIMETRIC IMMUNOASSAY?

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

What is the FDA product code for AXIS %CDT TURBIDIMETRIC IMMUNOASSAY?

The FDA product code for AXIS %CDT TURBIDIMETRIC IMMUNOASSAY is NAO.

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Related Devices (Code: NAO)

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.

K060677N LATEX CDTDade Behring, Inc.K001943CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAYSangui Biotech, Inc.

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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