FDA.reportPublic FDA data

NA

Primary DI
04582275250404
Brand
NA
Company
KONAN MEDICAL, INC.
Model
CD-15
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NQEMicroscope, specular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQEMicroscope, SpecularOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040373000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040373000KERATO ANALYZER (EKA)Konan Medical, Inc.2004-03-19NQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582275250404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275250404045822752504044582275250404

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, manualA mains electricity (AC-powered) manual laboratory instrument intended to be used for the qualitative microscopic examination of blood or other clinical specimens in order to view, count, record and evaluate the morphological characteristics of cells and other biological components. The device typically includes a microscope, camera, monitor and software package and operates with technician involvement in most procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690768619
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582275250671NACellChek 20-1 PLUS2023-09-27
04582275250664NACellChek 20-12022-04-07
04582275250657NACC 20 rc2021-06-25
04582275250626NACellChek 202020-04-02
04582275250107NANSP2016-08-29
04582275250374NANSPC2016-09-23
04582275250428NACellchek2016-09-23
04582275250619N/APOM2017-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852194002007EB-3000xyzHightech American Industrial Labs IncNQE2025-12-25
00852194002021EB-2000xyzHightech American Industrial Labs IncNQE2025-12-25
00852194002014HAI CL-1000xyz clinical specular microscopeHightech American Industrial Labs IncNQE2025-03-21
04582275250671NAKONAN MEDICAL, INC.NQE2023-09-27
04582275250664NAKONAN MEDICAL, INC.NQE2022-04-07
04582273603691SPECULAR MICROSCOPETOMEY CORPORATION.NQE2022-04-01
04582275250626NAKONAN MEDICAL, INC.NQE2020-04-02
04582273612822Specular MicroscopeTOMEY CORPORATION.NQE2018-03-06
04582275250374NAKONAN MEDICAL, INC.NQE2016-09-23
04562123288315SPECULAR MICROSCOPE SP-1PTOPCON CORPORATIONNQE2016-09-19
04987669100530SPECULAR MICROSCOPENIDEK CO.,LTD.NQE2016-08-26