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FDA 510(k)

N LP(A) STANDARD SY

K-Number: K013126 · 2001-11-09

ApplicantDade Behring, Inc.
Decision Date2001-11-09
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N LP(A) STANDARD SY is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K013126. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N LP(A) STANDARD SY?

N LP(A) STANDARD SY is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Dade Behring, Inc.. The 510(k) number is K013126.

When did N LP(A) STANDARD SY receive FDA 510(k) clearance?

N LP(A) STANDARD SY received FDA 510(k) clearance on 2001-11-09, under 510(k) number K013126.

Who is the listed applicant for N LP(A) STANDARD SY?

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

What is the FDA product code for N LP(A) STANDARD SY?

The FDA product code for N LP(A) STANDARD SY is JIS.

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Other records listing Dade Behring, 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: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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