Lipase Determination
FDA 510(k) K800550 · The Dow Chemical Co.
510(k) numberK800550
Submission
- Device name
- Lipase Determination
- Applicant
- The Dow Chemical Co.
Mchenry, IL, US - Received
- March 10, 1980
- Decision date
- April 2, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFG – Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1465
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K860554 | Serum Lipase Reagent Set (Turbidimetric)CFG · Traditional | Sterling Diagnostics, Inc. | 03/14/1986SE |
More from Sterling Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K823474 | Enzymatic Glucose DeterminationCGA · Traditional | 12/30/1982SE |
| K822154 | Urea Nitrogen (Enzymatic) DeterminationCDN · Traditional | 08/05/1982SE |
| K821536 | Dowflow Alt-Uv DeterminationCKA · Traditional | 06/14/1982SE |
| K821315 | Dowflow Enzymatic Triglycerides DetermCDT · Traditional | 05/24/1982SE |
| K820714 | Dow Bilirubin(Direct) DeterminationCIG · Traditional | 04/01/1982SE |
| K820675 | Bilirubin(Total) Determination CTMSCIG · Traditional | 04/01/1982SE |
| K812777 | Direct Iron Reagent SetJIY · Traditional | 10/19/1981SE |
| K811806 | Quick-Chem ColorimeterJJQ · Traditional | 07/15/1981SE |
| K810861 | Creatine Kinase MB Isoenzyme Immuno UVJHW · Traditional | 04/14/1981SE |
| K810727 | Ast-Uv (Plp-Activated) DeterminationCIT · Traditional | 03/31/1981SE |
Questions and answers
When was Lipase Determination cleared by the FDA?
Lipase Determination (K800550) received a 510(k) decision of Substantially Equivalent on April 2, 1980, 23 days after the submission was received.
What is the product code of K800550?
The FDA product code is CFG – Oil Emulsion/Thymolphthalein (Titrimetric), Lipase, a Class I (low risk) device regulated under 21 CFR 862.1465.