Identity
- Trade Name
- CardioChek® PA Professional Analyzer, Refurbished FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
- Device Name
- The CardioChek® PA professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. FDA UDI
- Model / Reference
- 1757 FDA UDI
- Description
- The CardioChek® PA professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen. FDA UDI
Identifiers
- Catalog Number
- 1757 FDA UDI
- Primary DI / UDI-DI
- 00381931757011 FDA UDI
- 510(k) Number
- K014099 FDA UDI
- FDA Product Code
- JGY FDA UDINBW FDA UDICHH FDA UDILBR FDA UDINGO FDA UDINAQ FDA UDICGA FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1705 FDA UDI862.1345 FDA UDI862.1175 FDA UDI862.1475 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
Yes
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, point-of-care
CardioChek® PA Professional Analyzer, Refurbished by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry analyser IVD, point-of-care.
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- i-STAT — Abbott Point of Care Inc. · Class II
- CardioChek — HENRY SCHEIN, INC. · Class I
- i-STAT — Abbott Point of Care Inc. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
Cleared under the same submission
K014099 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
- Polymer Technology Systems
Sources (1)
- FDA UDI e51c70a5-7dc6-4db4-8f63-1a2be63f8758 37 fields · synced Jun 8, 2026