510(k) K852767
- Device
- ERYTHOCYTE CREATINE
- Applicant
- PANMED, INC.
- 510(k) number
- K852767
- Product code
- JLA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-13
- Date received
- 1985-06-28
- Regulation
- 862.1210
- Classification name
- Conversion To Creatinine, Creatine
- Medical specialty
- Clinical Chemistry
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROGER VERN
- Address
- 505 W. Locust Three Oaks MI US 49128 49128
FDA Registration Numbers#
- 3008987086
- 3038206980
- 3021010433
- 3007301207
- 3043127699
- 9710666
- 2245451
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JLA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K854016 | ASSERACHROM PROTEIN C KIT | American Bioproducts Co. | 1986-01-03 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases