FDA 510(k)

GELMAN LIPOPROTEIN FRS SET. P/N 51213

K-Number: K791606 · 1979-09-17

Decision Date1979-09-17

Product CodeJHO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GELMAN LIPOPROTEIN FRS SET. P/N 51213 is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1979-09-17 under 510(k) number K791606. The device is classified under product code JHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELMAN LIPOPROTEIN FRS SET. P/N 51213?

GELMAN LIPOPROTEIN FRS SET. P/N 51213 is a medical device that received FDA 510(k) clearance on 1979-09-17. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K791606.

When did GELMAN LIPOPROTEIN FRS SET. P/N 51213 receive FDA 510(k) clearance?

GELMAN LIPOPROTEIN FRS SET. P/N 51213 received FDA 510(k) clearance on 1979-09-17, under 510(k) number K791606.

Who is the listed applicant for GELMAN LIPOPROTEIN FRS SET. P/N 51213?

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

What is the FDA product code for GELMAN LIPOPROTEIN FRS SET. P/N 51213?

The FDA product code for GELMAN LIPOPROTEIN FRS SET. P/N 51213 is JHO.

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Other records listing Gelman Sciences, Inc. as applicant

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Related Devices (Code: JHO)

K022333SPIFE LIPPOROTEIN-12, MODEL 3344Helena Laboratories K022053HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134Sebia K013662MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.K012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123Morax K013466SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343Helena Laboratories K010337LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.

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.