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FDA 510(k)

N-ASSAY TIA MULTI V-NL

K-Number: K964300 · 1997-07-14

ApplicantCrestat Diagnostics, Inc.
Decision Date1997-07-14
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N-ASSAY TIA MULTI V-NL is the device name listed in this FDA 510(k) record. The listed applicant is Crestat Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-07-14 under 510(k) number K964300. 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 N-ASSAY TIA MULTI V-NL?

N-ASSAY TIA MULTI V-NL is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Crestat Diagnostics, Inc.. The 510(k) number is K964300.

When did N-ASSAY TIA MULTI V-NL receive FDA 510(k) clearance?

N-ASSAY TIA MULTI V-NL received FDA 510(k) clearance on 1997-07-14, under 510(k) number K964300.

Who is the listed applicant for N-ASSAY TIA MULTI V-NL?

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

What is the FDA product code for N-ASSAY TIA MULTI V-NL?

The FDA product code for N-ASSAY TIA MULTI V-NL is DBI.

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Other records listing Crestat Diagnostics, Inc. as applicant

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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.

K100455SPAPLUS ANALYZERThe Binding SiteK012359TINA-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.

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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