ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION
FDA 510(k) clearance K883048 · decided 1988-08-17
Clearance details
- K-number
- K883048
- Device name
- ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION
- Applicant
- Alpha-Tec Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-16
- Decision date
- 1988-08-17
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- LDZ
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Irvine, CA, 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 |
|---|---|---|
| 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 |
| SACCOMANNO SPECIMAN SOLUTION (K862725) | Mill-Rose Laboratory | 1986-08-01 |
| 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.