KEO
11 FDA 510(k) clearances · Product code
28 daysmedian time to decision
36 days90th percentile
11clearances measured
FDA profile
- Official device name
- Formulations, Paraffin, All
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TISSUE EMBEDDING MEDIUM (K893772) | Stephens Scientific | 1989-06-22 |
| MICRO THIN* PARAFFIN (K862223) | Richard-Allan Medical Ind., Inc. | 1986-06-17 |
| HISTOLOGY PARAFFIN (K862141) | Erie Scientific Co. | 1986-06-13 |
| BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (K861270) | Surgipath Medical Industries, Inc. | 1986-04-11 |
| PARAPLAST EXTRA TISSUE EMBEDDING MED. (K842053) | Sherwood Medical Co. | 1984-06-26 |
| TECHNICON PARACUT (K833071) | Technicon Instruments Corp. | 1983-10-14 |
| PARAFFIN INFILTRATION MEDIUM (K831580) | Surgipath Medical Industries, Inc. | 1983-06-17 |
| VASPAR SEALENT (K812191) | American Scientific Products | 1981-08-31 |
| PARAFFIN EMBEDDING MEDIUM (K810568) | Surgipath Medical Industries, Inc. | 1981-03-17 |
| HISTOLOGICAL EMBEDDING MEDIA (K803241) | Miles Laboratories, Inc. | 1981-01-28 |
| SORVALL EMBEDDING MEDIUM (K760602) | E.I. Dupont DE Nemours & Co., Inc. | 1976-09-21 |
Track KEO automatically
Every clearance here is in the API, with alerts when new ones post.