510(k) K860554
- Device
- SERUM LIPASE REAGENT SET (TURBIDIMETRIC)
- Applicant
- STERLING DIAGNOSTICS, INC.
- 510(k) number
- K860554
- Product code
- CFG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-03-14
- Date received
- 1986-02-14
- 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#
- Contact
- DAVID L CALLENDER
- Address
- 34210 Dequindre Rd. Sterling Heights MI US 48077 48077
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 |
|---|---|---|---|
| K800550 | LIPASE DETERMINATION | The Dow Chemical Co. | 1980-04-02 |
Legacy Summary#
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FDA Review#
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