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FDA 510(k)

INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT

K-Number: K120169 · 2012-08-24

ApplicantGrifols USA, LLC
Decision Date2012-08-24
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Grifols USA, LLC. It received FDA 510(k) clearance on 2012-08-24 under 510(k) number K120169. 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 INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT?

INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT is a medical device that received FDA 510(k) clearance on 2012-08-24. The listed applicant is Grifols USA, LLC. The 510(k) number is K120169.

When did INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT receive FDA 510(k) clearance?

INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT received FDA 510(k) clearance on 2012-08-24, under 510(k) number K120169.

Who is the listed applicant for INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT?

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

What is the FDA product code for INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT?

The FDA product code for INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT is CFF.

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Other records listing Grifols USA, LLC 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.

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Related Devices (Code: CFF)

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.

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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.

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