FDA product code LDZ: Fixative, Alcohol Containing
LDZ is the FDA product code for fixative, alcohol containing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 8 510(k) submissions under LDZ, from 7 different applicants. The average 510(k) review took 78 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Fixative, Alcohol 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 LDZ clearance
Top LDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alpha-Tec Systems, Inc. | 2 | 1988-08-17 |
| Surgipath Medical Industries, Inc. | 1 | 1988-05-25 |
| Mill-Rose Laboratory | 1 | 1986-08-01 |
| Accra Laboratories, Inc. | 1 | 1984-09-27 |
| E K Ind., Inc. | 1 | 1984-09-07 |
2 more applicants have LDZ clearances. See the full list in Caduvo.
Most recent LDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883048 | Alpha-Tec Systems, Inc. | ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION | 1988-08-17 | 32 |
| K881922 | Surgipath Medical Industries, Inc. | CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE | 1988-05-25 | 16 |
| K881698 | Alpha-Tec Systems, Inc. | ATS PVA FIXATIVE SOLUTION | 1988-05-13 | 24 |
| K862725 | Mill-Rose Laboratory | SACCOMANNO SPECIMAN SOLUTION | 1986-08-01 | 15 |
| K843428 | Accra Laboratories, Inc. | BIOFIX | 1984-09-27 | 23 |
Recalls for LDZ devices
openFDA lists no recalls for product code LDZ.
Frequently asked questions
What is FDA product code LDZ?
LDZ is the FDA product code for fixative, alcohol containing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is LDZ?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LDZ?
Across 8 cleared submissions the average was 78 days from receipt to decision (median 28).
Which companies have the most LDZ clearances?
Alpha-Tec Systems, Inc. (2); Surgipath Medical Industries, Inc. (1); Mill-Rose Laboratory (1); Accra Laboratories, Inc. (1); E K Ind., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LDZ
- Run a recall and safety report across every LDZ manufacturer
- Watch product code LDZ 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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