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FDA 510(k)

PARAGON LIPOPROTEIN ELECTRO. REAG. KIT

K-Number: K802822 · 1980-12-11

ApplicantBeckman Instruments, Inc.
Decision Date1980-12-11
Product CodeJHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAGON LIPOPROTEIN ELECTRO. REAG. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802822. 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 PARAGON LIPOPROTEIN ELECTRO. REAG. KIT?

PARAGON LIPOPROTEIN ELECTRO. REAG. KIT is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K802822.

When did PARAGON LIPOPROTEIN ELECTRO. REAG. KIT receive FDA 510(k) clearance?

PARAGON LIPOPROTEIN ELECTRO. REAG. KIT received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802822.

Who is the listed applicant for PARAGON LIPOPROTEIN ELECTRO. REAG. KIT?

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

What is the FDA product code for PARAGON LIPOPROTEIN ELECTRO. REAG. KIT?

The FDA product code for PARAGON LIPOPROTEIN ELECTRO. REAG. KIT is JHO.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: JHO)

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.

K022333SPIFE LIPPOROTEIN-12, MODEL 3344Helena LaboratoriesK022053HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134SebiaK013662MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.K012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123MoraxK013466SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343Helena LaboratoriesK010337LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.

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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