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FDA 510(k)

HYDRAGEL PROTEIN(E) KIT

K-Number: K951536 · 1995-06-30

ApplicantSebia
Decision Date1995-06-30
Product CodeCEF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYDRAGEL PROTEIN(E) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 1995-06-30 under 510(k) number K951536. The device is classified under product code CEF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRAGEL PROTEIN(E) KIT?

HYDRAGEL PROTEIN(E) KIT is a medical device that received FDA 510(k) clearance on 1995-06-30. The listed applicant is Sebia. The 510(k) number is K951536.

When did HYDRAGEL PROTEIN(E) KIT receive FDA 510(k) clearance?

HYDRAGEL PROTEIN(E) KIT received FDA 510(k) clearance on 1995-06-30, under 510(k) number K951536.

Who is the listed applicant for HYDRAGEL PROTEIN(E) KIT?

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

What is the FDA product code for HYDRAGEL PROTEIN(E) KIT?

The FDA product code for HYDRAGEL PROTEIN(E) KIT is CEF.

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Related Devices (Code: CEF)

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.

K130500CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENTSebiaK972274SPIFEHelena LaboratoriesK973316REP SPE VIS-60/40 KITHelena LaboratoriesK963018BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESISBio-RadK964453REP 3 FLUR SPE-60 KITHelena LaboratoriesK960029HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KITMorax

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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