FDA product code LDW: Fixative, Acid Containing
LDW is the FDA product code for fixative, acid containing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 4 510(k) submissions under LDW, from 3 different applicants. The average 510(k) review took 44 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Fixative, Acid Containing |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LDW clearance
Top LDW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 2 | 1984-09-11 |
| Alpha-Tec Systems, Inc. | 1 | 1988-08-04 |
| American Micro Scan | 1 | 1983-06-08 |
Most recent LDW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883062 | Alpha-Tec Systems, Inc. | ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID | 1988-08-04 | 16 |
| K842923 | E K Ind., Inc. | PICRIC ACID 1% W/V | 1984-09-11 | 48 |
| K842922 | E K Ind., Inc. | PICRIC ACID SATURATED SOLUTION | 1984-09-07 | 44 |
| K831058 | American Micro Scan | SAF FIXATIVE | 1983-06-08 | 68 |
Recalls for LDW devices
openFDA lists no recalls for product code LDW.
Frequently asked questions
What is FDA product code LDW?
LDW is the FDA product code for fixative, acid containing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is LDW?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LDW?
Across 4 cleared submissions the average was 44 days from receipt to decision (median 46).
Which companies have the most LDW clearances?
E K Ind., Inc. (2); Alpha-Tec Systems, Inc. (1); American Micro Scan (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LDW
- Run a recall and safety report across every LDW manufacturer
- Watch product code LDW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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