Gen. Diag. Chromostrate ALPHA-2 Antiplasmin Assay
FDA 510(k) K850411 · Warner-Lambert Co.
510(k) numberK850411
Submission
- Device name
- Gen. Diag. Chromostrate ALPHA-2 Antiplasmin Assay
- Applicant
- Warner-Lambert Co.
Morris Plains, NJ, US - Received
- February 4, 1985
- Decision date
- May 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LGP – Assay, Alpha-2-Antiplasmin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
Other 510(k)s with product code LGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K864213 | Il Test 97572-15, Alpha 2-ANTIPLASMIN AssayLGP · Traditional | Instrumentation Laboratory CO | 11/25/1986SE |
| K833890 | Coatest AntiplasminLGP · Traditional | Kabivitrum, Inc. | 01/30/1984SE |
| K803110 | Proteolytic Enzyme ControlLGP · Traditional | American Dade | 02/17/1981SE |
| K802840 | Alpha-Antiplasm AssayLGP · Traditional | American Dade | 02/17/1981SE |
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Questions and answers
When was Gen. Diag. Chromostrate ALPHA-2 Antiplasmin Assay cleared by the FDA?
Gen. Diag. Chromostrate ALPHA-2 Antiplasmin Assay (K850411) received a 510(k) decision of Substantially Equivalent on May 8, 1985, 93 days after the submission was received.
What is the product code of K850411?
The FDA product code is LGP – Assay, Alpha-2-Antiplasmin, a Class II (moderate risk) device regulated under 21 CFR 864.5425.