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FDA 510(k)

NEOCOAT T4

K-Number: K901939 · 1990-05-31

ApplicantNeometrics, Inc.
Decision Date1990-05-31
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEOCOAT T4 is the device name listed in this FDA 510(k) record. The listed applicant is Neometrics, Inc.. It received FDA 510(k) clearance on 1990-05-31 under 510(k) number K901939. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOCOAT T4?

NEOCOAT T4 is a medical device that received FDA 510(k) clearance on 1990-05-31. The listed applicant is Neometrics, Inc.. The 510(k) number is K901939.

When did NEOCOAT T4 receive FDA 510(k) clearance?

NEOCOAT T4 received FDA 510(k) clearance on 1990-05-31, under 510(k) number K901939.

Who is the listed applicant for NEOCOAT T4?

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

What is the FDA product code for NEOCOAT T4?

The FDA product code for NEOCOAT T4 is CDX.

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Other records listing Neometrics, 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.

K123439NEO ERCP GUIDEWIREK101729NEOWIRE PTA/PTCA GUIDEWIREK070150VASCUPUNCTURE PICC GUIDEWIREK043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREK040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATINGK033321SELECTIVA SB GUIDEWIRE

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Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.

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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