SACCOMANNO SPECIMAN SOLUTION
FDA 510(k) clearance K862725 · decided 1986-08-01
Clearance details
- K-number
- K862725
- Device name
- SACCOMANNO SPECIMAN SOLUTION
- Applicant
- Mill-Rose Laboratory
- Decision
- Substantially Equivalent
- Date received
- 1986-07-17
- Decision date
- 1986-08-01
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- LDZ
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mill-Rose Laboratory
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (K883048) | Alpha-Tec Systems, Inc. | 1988-08-17 |
| CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (K881922) | Surgipath Medical Industries, Inc. | 1988-05-25 |
| ATS PVA FIXATIVE SOLUTION (K881698) | Alpha-Tec Systems, Inc. | 1988-05-13 |
| BIOFIX (K843428) | Accra Laboratories, Inc. | 1984-09-27 |
| WRIGHT STAIN FIXATIVE (K842913) | E K Ind., Inc. | 1984-09-07 |
| PVA FIXATIVE/FORMALIN (K831061) | American Micro Scan | 1983-06-08 |
| FA TISSUE FIXATIVE & WASH SET (K761138) | Zeus Scientific, Inc. | 1978-01-06 |
Recalls involving this device
No recalls on record reference this clearance.