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FDA 510(k)

LIPPOPROTEIN ELECTROPHORESIS REAGENT SET

K-Number: K771812 · 1977-10-18

ApplicantGelman Instrument Co.
Decision Date1977-10-18
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LIPPOPROTEIN ELECTROPHORESIS REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Instrument Co.. It received FDA 510(k) clearance on 1977-10-18 under 510(k) number K771812. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPPOPROTEIN ELECTROPHORESIS REAGENT SET?

LIPPOPROTEIN ELECTROPHORESIS REAGENT SET is a medical device that received FDA 510(k) clearance on 1977-10-18. The listed applicant is Gelman Instrument Co.. The 510(k) number is K771812.

When did LIPPOPROTEIN ELECTROPHORESIS REAGENT SET receive FDA 510(k) clearance?

LIPPOPROTEIN ELECTROPHORESIS REAGENT SET received FDA 510(k) clearance on 1977-10-18, under 510(k) number K771812.

Who is the listed applicant for LIPPOPROTEIN ELECTROPHORESIS REAGENT SET?

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

What is the FDA product code for LIPPOPROTEIN ELECTROPHORESIS REAGENT SET?

The FDA product code for LIPPOPROTEIN ELECTROPHORESIS REAGENT SET is DFC.

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Other records listing Gelman Instrument Co. 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.

K772074RADIAL IMMUNODIFFUSION KIT-TRANSFERRINK772077RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.GK772080RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTITK772076RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.K772079RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.MK772075RADIAL IMMUNODIFFUSION KIT-COMPLEMENT

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Related Devices (Code: DFC)

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.

K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.K241220Tina-quant Lipoprotein(a) Gen.2 MolarityRoche Diagnostics OperationsK211058Lp(a) UltraSENTINEL CH. SpAK180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics, Inc.K122722COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics

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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