Flame photometer standard 140 Na 5K - Flame photometer standard 140 Na 5K - INSTRUMENTATION LABORATORY COMPANY

Duns Number:557223252

Device Description: Flame photometer standard 140 Na 5K

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More Product Details

Catalog Number

00009751750

Brand Name

Flame photometer standard 140 Na 5K

Version/Model Number

00009751750

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K823480,K823480

Product Code Details

Product Code

JJO

Product Code Name

FLAME EMISSION PHOTOMETER FOR CLINICAL USE

Device Record Status

Public Device Record Key

870083bb-0262-452f-b470-6d0bdc39e6d8

Public Version Date

July 07, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSTRUMENTATION LABORATORY COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 272