FDA.reportPublic FDA data

SPOTCHECK

Primary DI
00725609000342
Brand
SPOTCHECK
Company
ASTORIA-PACIFIC, INC.
Model
307-A990-00
Catalog number
307-A990-00
Device description
G6PD Cartridge
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101392000NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350DAstoria-Pacific, Inc.2011-02-04KQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00725609000342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00725609000342007256090003427256090003420725609000342

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel clinical chemistry analyser IVD, laboratory, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents and incorporates multiple channels using more two or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. 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
623238615
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00725609000595SPOTCHECK81-2500-05K81-2500-05K2020-12-17
00725609000076SPOTCHECK80-8000-13K80-8000-13K2016-10-14
00725609000083SPOTCHECK80-8000-CA80-8000-CA2016-10-14
00725609000090SPOTCHECK81-2000-20K81-2000-20K2016-10-14
00725609000106SPOTCHECK81-2000-60K81-2000-60K2016-10-14
00725609000113SPOTCHECK81-4000-20K81-4000-20K2016-10-14
00725609000120SPOTCHECK81-4000-60K81-4000-60K2016-10-14
00725609000137SPOTCHECK81-8000-13K81-8000-13K2016-10-14
00725609000144SPOTCHECK81-8000-60K81-8000-60K2016-10-14
00725609000199Accuwell6020-20-EGAL6020-20-EGAL2016-10-14
00725609000205SPOTCHECK80-0900-01K80-0900-01K2016-10-14
00725609000212SPOTCHECK80-0901P4K80-0901P4K2016-10-14
00725609000267SPOTCHECK910-0500-00910-0500-002016-10-14
00725609000441SPOTCHECK80-0900P4K80-0900P4K2016-10-14
00725609000458SPOTCHECK80-0901-01K80-0901-01K2016-10-14
00725609000274SPOTCHECK302-A100-03302-A100-032016-10-14
00725609000281SPOTCHECK302-A100-03EX302-A100-03EX2016-10-14
00725609000298SPOTCHECK303-A000-03303-A000-032016-10-14
00725609000304SPOTCHECK303-A002-03303-A002-032016-10-14
00725609000311SPOTCHECK303-A003-03303-A003-032016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810044208351Caplugs/EvergreenCAPlugsJJC2026-02-06
00810044208368Caplugs/EvergreenCAPlugsJJC2026-02-06
00810044208375Caplugs/EvergreenCAPlugsJJC2026-02-06
00810044208382Caplugs/EvergreenCAPlugsJJC2026-02-06
00810044200959Caplugs/EvergreenCAPlugsJJC2020-10-14
00810044200607Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200614Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200621Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200638Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200645Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200652Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200669Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200676Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200683Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200690Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200829Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200836Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200843Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200850Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200867Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200874Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200881Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200898Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200904Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200911Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200522Caplugs/EvergreenCAPlugsJJC2020-06-19
00810044200539Caplugs/EvergreenCAPlugsJJC2020-06-19
00810044200546Caplugs/EvergreenCAPlugsJJC2020-06-19
00810044200553Caplugs/EvergreenCAPlugsJJC2020-06-19
00810044200560Caplugs/EvergreenCAPlugsJJC2020-06-19