Identity
- Trade Name
- Adstation™ FDA UDI
- Generic Name
- Ophthalmic/otologic diagnostic set FDA UDI
- Device Name
- Diagnostix Portable Set, 3.5v,OtoX/OphL, Soft FDA UDI
- Model / Reference
- 5410BS FDA UDI
- Description
- Diagnostix Portable Set, 3.5v,OtoX/OphL, Soft FDA UDI
Identifiers
- Catalog Number
- 5410BS FDA UDI
- Primary DI / UDI-DI
- 00634782084134 FDA UDI
- 510(k) Number
- K932506 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Ophthalmic/otologic diagnostic set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic/otologic diagnostic set
Adstation™ by American Diagnostic Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic/otologic diagnostic set.
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
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- May-ophthalmoscope head XL 3.5 V, — Rudolf Riester GmbH & Co. KG · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
K932506 also covers:
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
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
- American Diagnostic Corporation
Sources (1)
- FDA UDI a72a679c-f66e-477a-9c74-06ce854e9f53 37 fields · synced Jun 8, 2026