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FDA 510(k)

TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION

K-Number: K981914 · 1999-11-26

ApplicantThe Binding Site, Ltd.
Decision Date1999-11-26
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 1999-11-26 under 510(k) number K981914. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION?

TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K981914.

When did TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION receive FDA 510(k) clearance?

TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION received FDA 510(k) clearance on 1999-11-26, under 510(k) number K981914.

Who is the listed applicant for TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION?

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

What is the FDA product code for TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION?

The FDA product code for TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION is JJX.

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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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