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FDA 510(k)

PARAGON ELECTROPHORESIS LACTATE REAG.KIT

K-Number: K802628 · 1980-12-11

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

Device Summary

PARAGON ELECTROPHORESIS LACTATE 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 K802628. The device is classified under product code CFE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAGON ELECTROPHORESIS LACTATE REAG.KIT?

PARAGON ELECTROPHORESIS LACTATE 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 K802628.

When did PARAGON ELECTROPHORESIS LACTATE REAG.KIT receive FDA 510(k) clearance?

PARAGON ELECTROPHORESIS LACTATE REAG.KIT received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802628.

Who is the listed applicant for PARAGON ELECTROPHORESIS LACTATE 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 ELECTROPHORESIS LACTATE REAG.KIT?

The FDA product code for PARAGON ELECTROPHORESIS LACTATE REAG.KIT is CFE.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: CFE)

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.

K100307GELSCAN, MODEL 1206SebiaK022455SPIFE LD-12 KIT, MODEL 3338Helena LaboratoriesK020467SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452Helena LaboratoriesK970477HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KITSebiaK940224CARDIO REP LDHelena LaboratoriesK921455ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHODE.I. Dupont DE Nemours & Co., Inc.

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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