510(k) K800550
- Device
- Lipase Determination
- Applicant
- THE DOW CHEMICAL CO.
- 510(k) number
- K800550
- Product code
- CFG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-04-02
- Date received
- 1980-03-10
- Regulation
- 862.1465
- Classification name
- Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2024311
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CFG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K860554 | SERUM LIPASE REAGENT SET (TURBIDIMETRIC) | Sterling Diagnostics, Inc. | 1986-03-14 |