Identity
- Trade Name
- ACCELERATOR FDA UDI
- Generic Name
- Specimen processing instrument IVD FDA UDI
- Device Name
- ACCELERATOR APS INPUT/OUTPUT MODULE FDA UDI
- Model / Reference
- 07L0102 FDA UDI
- Description
- ACCELERATOR APS INPUT/OUTPUT MODULE FDA UDI
Identifiers
- Catalog Number
- 07L0102 FDA UDI
- Primary DI / UDI-DI
- 00380740028862 FDA UDI
- 510(k) Number
- K093318 FDA UDI
- FDA Product Code
- JQP FDA UDI
- GMDN Term
- Specimen processing instrument IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2100 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: Specimen processing instrument IVD
Accelerator by Abbott Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K093318 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
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI ad839acb-ef1e-4cef-9e38-8be03cd192d0 36 fields · synced May 31, 2026