Biotel (Tm)/Uti
510(k) K855238
Biotel (Tm)/Uti is a Class I device made by American Diagnostic Corp., cleared under FDA 510(k) K855238 on 9 May 1986, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK855238 | Date9 May 1986 | StatusActive |
Official records
- FDA 510(k) database K855238
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JMT
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1510
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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