FDA.reportPublic FDA data

SelectaLyte

Primary DI
00850229007287
Brand
SelectaLyte
Company
AWARENESS TECHNOLOGY, INCORPORATED
Model
3910
Published
2019-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171476000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171476000SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc.2018-02-27JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850229007287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850229007287008502290072878502290072870850229007287

GMDN Terms#

Term, Definition table
TermDefinition
Ion-selective analyser IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071065130
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850229007089StatFax 22002023-06-05
00850229007010StatFax47002023-06-05
00850229007027StatFax45002023-06-05
00850229007034StatFax42002023-06-05
00850229007041StatFax33002023-06-05
00850229007072StatFax26002023-06-05
00850229007102StatFax1904+2023-06-05
00850229007126LumiStat49002023-06-05
00850229007140LuMate44002023-06-05
00850229007201ChroMate43002023-06-05
00850229007218ChemWell-T46202023-06-05
00850229007232ChemWell29102023-06-05
00850229007461ChemWell251002023-06-05
00850229007119Redi-Check Photometer QCRedi-Check Photometer QCE3052016-06-30
00850229007164DriDye 492492E002-4922016-06-30
00850229007171DriDye 450450E002-4502016-06-30
00850229007188DriDye 405/ 450405/ 4502016-06-30
00850229007195DriDye 405405E002-4052016-06-30
00850229007225ChemWell® FUSION480048002022-03-03
00850229007324SelectaLyte (Sodium Electrode)39102019-06-26

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Primary DI, Brand, Company table
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00810053950449NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
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00810053950463NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950494NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879023770NOVEOS Sesame Seed, Sesamum indicumHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024203NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024333NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024470NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024982NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025323NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025354NOVEOS Soybean, Glycine maxHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025378NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879027341NOVEOS Hazelnut, Corylus avellanaHYCOR BIOMEDICAL LLCJJE2026-07-29
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00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
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