Identity
- Trade Name
- SPOTCHECK FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- SPOTCHECK Pro FDA UDI
- Model / Reference
- 910-0500-00 FDA UDI
- Description
- SPOTCHECK Pro FDA UDI
Identifiers
- Catalog Number
- 910-0500-00 FDA UDI
- Primary DI / UDI-DI
- 00725609000267 FDA UDI
- 510(k) Number
- K102643 FDA UDI
- FDA Product Code
- JJQ FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2300 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: Multiple clinical chemistry analyser IVD, laboratory
Spotcheck by Astoria-Pacific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102643 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Astoria-Pacific, Inc.
Sources (1)
- FDA UDI 80050ee3-8f87-45e8-ad9f-cb5f643768a7 35 fields · synced May 30, 2026