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FDA 510(k)

SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389

K-Number: K024162 · 2003-02-19

ApplicantHelena Laboratories
Decision Date2003-02-19
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2003-02-19 under 510(k) number K024162. The device is classified under product code CFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389?

SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 is a medical device that received FDA 510(k) clearance on 2003-02-19. The listed applicant is Helena Laboratories. The 510(k) number is K024162.

When did SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 receive FDA 510(k) clearance?

SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 received FDA 510(k) clearance on 2003-02-19, under 510(k) number K024162.

Who is the listed applicant for SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389?

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

What is the FDA product code for SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389?

The FDA product code for SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 is CFF.

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Related Devices (Code: CFF)

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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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