FDA 510(k)

TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION

K-Number: K981915 · 1999-12-20

Decision Date1999-12-20

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT 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 1999-12-20 under 510(k) number K981915. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION?

TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K981915.

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

TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION received FDA 510(k) clearance on 1999-12-20, under 510(k) number K981915.

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

The FDA product code for TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION is JJY.

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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.