Triglyceride Kit
FDA 510(k) K771068 · Environmental Chemical Specialties
510(k) numberK771068
Submission
- Device name
- Triglyceride Kit
- Applicant
- Environmental Chemical Specialties
Mchenry, IL, US - Received
- June 13, 1977
- Decision date
- July 12, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGM – Flame Photometry, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K895718 | Lithium Concentrate for a Flame PhotometerJGM · Traditional | Data Medical Associates, Inc. | 10/19/1989SE |
| K862300 | Amresco Flow Pac Sodium Potassium ReagentJGM · Traditional | Amresco, Inc. | 07/29/1986SE |
| K831300 | MSI-NAK-50 Test KitJGM · Traditional | Medical Specialties, Inc. | 07/18/1983SE |
| K810253 | Sodium & Potassium Test KitJGM · Traditional | Mallinckrodt Critical Care | 02/10/1981SE |
More from Mallinckrodt Critical Care
| 510(k) | Device | Decision |
|---|---|---|
| K812635 | Anemia ControlJJY · Traditional | 10/02/1981SE |
| K811810 | Uric Acid TestKNK · Traditional | 07/15/1981SE |
| K811811 | TDM Anti-Convulsant Control Levels I-IiDIF · Traditional | 07/10/1981SE |
| K811809 | Anti-Arrhythmic Control Levels I & IIDIF · Traditional | 07/10/1981SE |
| K803089 | Gamma-Glutamyl Transpeptidase (GGT)JPZ · Traditional | 01/02/1981SE |
| K792377 | Carcinoembryonic Antigen (Cea) ControlDHX · Traditional | 09/26/1980SE |
| K801854 | Spinal Fluid Control(Human)JJX · Traditional | 09/16/1980SE |
| K801061 | Total Protein TestCEK · Traditional | 07/21/1980SE |
| K792376 | Quantitative Control Urine II (Human)JJW · Traditional | 12/06/1979SE |
| K792375 | Elevated Lipid ControlJJY · Traditional | 12/06/1979SE |
Questions and answers
When was Triglyceride Kit cleared by the FDA?
Triglyceride Kit (K771068) received a 510(k) decision of Substantially Equivalent on July 12, 1977, 29 days after the submission was received.
What is the product code of K771068?
The FDA product code is JGM – Flame Photometry, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.