TISSUE EMBEDDING MEDIUM
FDA 510(k) clearance K893772 · decided 1989-06-22
Clearance details
- K-number
- K893772
- Device name
- TISSUE EMBEDDING MEDIUM
- Applicant
- Stephens Scientific
- Decision
- Substantially Equivalent
- Date received
- 1989-05-22
- Decision date
- 1989-06-22
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- KEO
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Denville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.