LGPClass II
Assay, Alpha-2-Antiplasmin
21 CFR 864.5425 / Hematology
LGP is the FDA product code for Assay, Alpha-2-Antiplasmin, a class II device type, regulated under 21 CFR 864.5425. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- LGP
- Device name
- Assay, Alpha-2-Antiplasmin
- Regulation
- 21 CFR 864.5425
- Device class
- Class II
- Review panel
- Hematology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code LGP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
Applicants with the most clearances
Product code LGP| Applicant | Clearances |
|---|---|
| American Dade | 2 |
| Instrumentation Laboratory Co. | 1 |
| Kabivitrum, Inc. | 1 |
| Warner-Lambert Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code LGP.
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