← Back to catalogue

Spotcheck

FDA UDI

Class I (US FDA UDI)

by Astoria-Pacific, Inc.

Identity

Trade Name
SPOTCHECK FDA UDI
Generic Name
Multichannel clinical chemistry analyser IVD, laboratory FDA UDI
Device Name
Uridyltransferase Blank Cartridge FDA UDI
Model / Reference
303-A980-00B FDA UDI
Description
Uridyltransferase Blank Cartridge FDA UDI

Identifiers

Catalog Number
303-A980-00B FDA UDI
Primary DI / UDI-DI
00725609000502 FDA UDI
510(k) Number
K883020 FDA UDI
FDA Product Code
JJF FDA UDI
GMDN Term
Multichannel clinical chemistry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2170 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multichannel clinical chemistry analyser IVD, laboratory

Spotcheck by Astoria-Pacific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multichannel clinical chemistry analyser IVD, laboratory.

Cleared under the same submission

K883020 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Astoria-Pacific, Inc.

Sources (1)

  • FDA UDI 9ea6989b-a870-4680-bed9-1642acda68f3 35 fields · synced Jun 8, 2026