Diagnostix™ 5460
by American Diagnostic Corporation
Diagnostix™ 5460 is a Class I device made by American Diagnostic Corporation, cleared under FDA 510(k) K932506 on 8 Oct 1993 and listed in FDA GUDID since 17 May 2019 (UDI-DI 00634782076290), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00634782076290 | Date17 May 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK932506 | Date8 Oct 1993 | StatusActive |
Official records
- AccessGUDID record 00634782076290
- FDA 510(k) database K932506
Across registries
- FDA 510(k) K932506 decided 8 Oct 1993 Active
- FDA GUDID UDI-DI 00634782076290 listed 17 May 2019 Listed
Timeline
- Cleared FDA 510(k) K932506
- Listed FDA GUDID 00634782076290
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diagnostix™
- Generic name
- Ophthalmic/otologic diagnostic set
- Model / Ref / Catalog
- 5460
- Primary DI / UDI-DI
- 00634782076290
- 510(k) Number
- FDA product code
- ERA
- GMDN term
- Ophthalmic/otologic diagnostic set
- Device class
- Class I
- Regulation number
- 874.4770
- GUDID distribution status
- Not in Commercial Distribution
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