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FDA 510(k)

SPAPLUS ANALYZER

K-Number: K100455 · 2010-09-03

ApplicantThe Binding Site
Decision Date2010-09-03
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPAPLUS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site. It received FDA 510(k) clearance on 2010-09-03 under 510(k) number K100455. The device is classified under product code DBI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPAPLUS ANALYZER?

SPAPLUS ANALYZER is a medical device that received FDA 510(k) clearance on 2010-09-03. The listed applicant is The Binding Site. The 510(k) number is K100455.

When did SPAPLUS ANALYZER receive FDA 510(k) clearance?

SPAPLUS ANALYZER received FDA 510(k) clearance on 2010-09-03, under 510(k) number K100455.

Who is the listed applicant for SPAPLUS ANALYZER?

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

What is the FDA product code for SPAPLUS ANALYZER?

The FDA product code for SPAPLUS ANALYZER is DBI.

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Other records listing The Binding Site 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.

K132555HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITK103824HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSK092450HUMAN IGD KIT FOR USE ON SPAPLUSK072166CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERK042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITK042152BINDING SITE IGG SUBLCASS OLYMPUS KITS

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Related Devices (Code: DBI)

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.

K012359TINA-QUANT COMPLEMENT C4 TEST SYSTEMRoche Diagnostics Corp.K010325WAKO AUTOKIT C4Wako Chemicals USA, Inc.K000468RANDOX COMPLEMENT C4Randox Laboratories, Ltd.K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.K981785C4 MININEPH ANTISERUMThe Binding Site, Ltd.K993481K-ASSAY C4Kamiya Biomedical Co.

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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