FDA product code LGP: Assay, Alpha-2-Antiplasmin
LGP is the FDA product code for assay, alpha-2-antiplasmin. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel. FDA has cleared 5 510(k) submissions under LGP, from 4 different applicants. The average 510(k) review took 74 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Assay, Alpha-2-Antiplasmin |
| Device class | Class II |
| Regulation | 21 CFR 864.5425 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LGP clearance
Top LGP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Dade | 2 | 1981-02-17 |
| Instrumentation Laboratory CO | 1 | 1986-11-25 |
| Warner-Lambert Co. | 1 | 1985-05-08 |
| Kabivitrum, Inc. | 1 | 1984-01-30 |
Most recent LGP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K864213 | Instrumentation Laboratory CO | IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY | 1986-11-25 | 28 |
| K850411 | Warner-Lambert Co. | GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY | 1985-05-08 | 93 |
| K833890 | Kabivitrum, Inc. | COATEST ANTIPLASMIN | 1984-01-30 | 82 |
| K803110 | American Dade | PROTEOLYTIC ENZYME CONTROL | 1981-02-17 | 69 |
| K802840 | American Dade | ALPHA-ANTIPLASM ASSAY | 1981-02-17 | 97 |
Recalls for LGP devices
openFDA lists no recalls for product code LGP.
Frequently asked questions
What is FDA product code LGP?
LGP is the FDA product code for assay, alpha-2-antiplasmin. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel.
What device class is LGP?
Class II, regulation 21 CFR 864.5425. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGP?
Across 5 cleared submissions the average was 74 days from receipt to decision (median 82).
Which companies have the most LGP clearances?
American Dade (2); Instrumentation Laboratory CO (1); Warner-Lambert Co. (1); Kabivitrum, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LGP
- Run a recall and safety report across every LGP manufacturer
- Watch product code LGP 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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