PVA FIXATIVE/FORMALIN
FDA 510(k) clearance K831061 · decided 1983-06-08
Clearance details
- K-number
- K831061
- Device name
- PVA FIXATIVE/FORMALIN
- Applicant
- American Micro Scan
- Decision
- Substantially Equivalent
- Date received
- 1983-04-01
- Decision date
- 1983-06-08
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- LDZ
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| 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 |
| 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 |
| FA TISSUE FIXATIVE & WASH SET (K761138) | Zeus Scientific, Inc. | 1978-01-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MIC PANELS (N62160/S013) | American Micro Scan | 1985-03-05 |
| MIC PANELS (N62160/S011) | American Micro Scan | 1984-01-30 |
| MIC PANELS (N62160/S012) | American Micro Scan | 1984-01-30 |
| MIC PANELS (N62160/S010) | American Micro Scan | 1983-10-12 |
| MIC PANELS (N62160/S009) | American Micro Scan | 1983-09-28 |
| MIC PANELS (N62160/S008) | American Micro Scan | 1983-08-10 |
| MIC PANELS (N62160/S007) | American Micro Scan | 1983-02-03 |
| MIC PANELS (N62160/S006) | American Micro Scan | 1982-11-18 |