510(k) K810253
- Device
- SODIUM & POTASSIUM TEST KIT
- Applicant
- MALLINCKRODT CRITICAL CARE
- 510(k) number
- K810253
- Product code
- JGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-02-10
- Date received
- 1981-01-30
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K862300 | AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT | Amresco, Inc. | 1986-07-29 |
| K831300 | MSI-NAK-50 TEST KIT | Medical Specialties, Inc. | 1983-07-18 |
| K771068 | TRIGLYCERIDE KIT | Environmental Chemical Specialties | 1977-07-12 |
Legacy Summary#
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FDA Review#
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