Lypoprotein Cholesterol Test Kit
FDA 510(k) K780173 · Environmental Chemical Specialties
510(k) numberK780173
Submission
- Device name
- Lypoprotein Cholesterol Test Kit
- Applicant
- Environmental Chemical Specialties
Mchenry, IL, US - Received
- February 2, 1978
- Decision date
- May 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHM – Colorimetric Method, Lipoproteins
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120662 | Piccolo Hdl-Capillary Test SystemJHM · Traditional | Abaxis, Inc. | 04/24/2012SE |
| K081300 | Dimension Vista HDLC Flex Reagent CartridgeJHM · Special | Siemens Healthcare Diagnostics | 07/02/2008SE |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional | Dade Behring, Inc. | 02/21/2008SE |
| K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48AJHM · Traditional | Dade Behring, Inc. | 10/30/2003SE |
| K022519 | LDL Cholesterol (Automated)JHM · Traditional | Jas Diagnostics, Inc. | 09/30/2002SE |
| K983849 | Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent CartridgeJHM · Traditional | Dade Behring, Inc. | 01/11/1999SE |
| K902935 | Roche Cobas Ready HDL Cholesterol ReagentJHM · Traditional | Roche Diagnostic Systems, Inc. | 09/27/1990SE |
| K841056 | HDL Precipitant Reagent SetJHM · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
More from Medical Specialties, Inc.
| 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 Lypoprotein Cholesterol Test Kit cleared by the FDA?
Lypoprotein Cholesterol Test Kit (K780173) received a 510(k) decision of Substantially Equivalent on May 3, 1978, 90 days after the submission was received.
What is the product code of K780173?
The FDA product code is JHM – Colorimetric Method, Lipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.