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FDA 510(k)

IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT

K-Number: K103757 · 2011-10-13

ApplicantGrifols
Decision Date2011-10-13
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Grifols. It received FDA 510(k) clearance on 2011-10-13 under 510(k) number K103757. 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 IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT?

IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT is a medical device that received FDA 510(k) clearance on 2011-10-13. The listed applicant is Grifols. The 510(k) number is K103757.

When did IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT receive FDA 510(k) clearance?

IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT received FDA 510(k) clearance on 2011-10-13, under 510(k) number K103757.

Who is the listed applicant for IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT?

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

What is the FDA product code for IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT?

The FDA product code for IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT is CFF.

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Related Devices (Code: CFF)

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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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