510(k) K862300
- Device
- AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT
- Applicant
- AMRESCO, INC.
- 510(k) number
- K862300
- Product code
- JGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-07-29
- Date received
- 1986-06-17
- Regulation
- 862.1600
- Classification name
- Flame Photometry, Potassium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIMOTHY J BELCASTRO
- Address
- 30175 Solon Industrial Pkwy. Solon OH US 44139 44139
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JGM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K895718 | LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER | Data Medical Associates, Inc. | 1989-10-19 |
| K831300 | MSI-NAK-50 TEST KIT | Medical Specialties, Inc. | 1983-07-18 |
| K810253 | SODIUM & POTASSIUM TEST KIT | Mallinckrodt Critical Care | 1981-02-10 |
| K771068 | TRIGLYCERIDE KIT | Environmental Chemical Specialties | 1977-07-12 |
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