Proteolytic Enzyme Control
FDA 510(k) K803110 · American Dade
510(k) numberK803110
Submission
- Device name
- Proteolytic Enzyme Control
- Applicant
- American Dade
Mchenry, IL, US - Received
- December 10, 1980
- Decision date
- February 17, 1981
- 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 |
| K850411 | Gen. Diag. Chromostrate ALPHA-2 Antiplasmin AssayLGP · Traditional | Warner-Lambert Co. | 05/08/1985SE |
| K833890 | Coatest AntiplasminLGP · Traditional | Kabivitrum, Inc. | 01/30/1984SE |
| K802840 | Alpha-Antiplasm AssayLGP · Traditional | American Dade | 02/17/1981SE |
More from American Dade
| 510(k) | Device | Decision |
|---|---|---|
| K873051 | Stratus(R) HFSH Fluorometric Enzyme ImmunoassayCGJ · Traditional | 10/20/1987SE |
| K873171 | Stratus(R) Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 09/29/1987SE |
| K873052 | Stratus(R) HLH Fluorometric Enzyme ImmunoassayCEP · Traditional | 09/14/1987SE |
| K872789 | Paramax Urine/Csf CalibratorJIX · Traditional | 09/02/1987SE |
| K872195 | Data-Fi Dimertest Latex AssayDAP · Traditional | 08/06/1987SE |
| K872196 | Aqueous Blood Gas/Electrolyte Contr Lev I,Ii & IIIJJS · Traditional | 07/31/1987SE |
| K871972 | Stratus Ige Fluorometric Enzyme ImmunoassayDGE · Traditional | 07/21/1987SE |
| K871977 | Dade Moni-Trol Chemistry Control/CalibratorJJY · Traditional | 07/09/1987SE |
| K872050 | Paramax Cholesterol ReagentLBS · Traditional | 07/07/1987SE |
| K872360 | Data-Fi Fibrin(Ogen) Degradation Prod.(Fdp)Det SetGHH · Traditional | 07/06/1987SE |
Questions and answers
When was Proteolytic Enzyme Control cleared by the FDA?
Proteolytic Enzyme Control (K803110) received a 510(k) decision of Substantially Equivalent on February 17, 1981, 69 days after the submission was received.
What is the product code of K803110?
The FDA product code is LGP – Assay, Alpha-2-Antiplasmin, a Class II (moderate risk) device regulated under 21 CFR 864.5425.