FDA.reportPublic FDA data

SPOTCHECK

Primary DI
00725609000434
Brand
SPOTCHECK
Company
ASTORIA-PACIFIC, INC.
Model
307-C001-00
Catalog number
307-C001-00
Device description
NeoPac Software with Manual
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
00725609000434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00725609000434007256090004347256090004340725609000434

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

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