Biotel (Tm)/ Kidney
510(k) K855237
Biotel (Tm)/ Kidney is a Class II device made by American Diagnostic Corp., cleared under FDA 510(k) K855237 on 6 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 | NumberK855237 | Date6 May 1986 | StatusActive |
Official records
- FDA 510(k) database K855237
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KHE
- Device class
- Class II
- Regulation
- 21 CFR Part 864.6550
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KHE (Reagent, Occult Blood).
- Propper Seracult by PROPPER MFG. CO., INC.
- Hemawipe System by Labeltape Meditect, Inc.
- Helena ColoCheck by Helena Laboratories, Corp.
- Colon Alert Test by IMMUNOSTICS, INC.
- COLORECTAL CANCER RISK DETECTOR (TM) by Pearce Clinical Laboratories, Inc.
- EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL by Nms Pharmaceuticals, Inc.
- SERACULT OCCULT BLOOF TEST by PROPPER MFG. CO., INC.
- EARLY DETECTOR by Warner-Lambert Co.
- INSURE II by ENTERIX INC.
- HEMAPROMPT GASTRIC by AERSCHER DIAGNOSTICS