HDL Cholesterol-E
FDA 510(k) K863065 · J. D. Assoc.
510(k) numberK863065
Submission
- Device name
- HDL Cholesterol-E
- Applicant
- J. D. Assoc.
Montclair, NJ, US - Received
- August 12, 1986
- Decision date
- September 25, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from J. D. Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K863103 | Peg 6,000CHH · Traditional | 01/13/1987SE |
| K863054 | Ast S.C.E. (Got)CIT · Traditional | 01/13/1987SE |
| K863069 | MagnesiometerJGJ · Traditional | 12/31/1986SE |
| K863079 | CreatinkineticCGX · Traditional | 12/12/1986SE |
| K863112 | ProteinmeterJGP · Traditional | 12/10/1986SE |
| K863068 | LDH S.C.E.CFJ · Traditional | 12/10/1986SE |
| K863053 | Alt S.C.E. (GPT)CKA · Traditional | 12/10/1986SE |
| K863066 | TransfermeterJQF · Traditional | 12/04/1986SE |
| K863109 | FerrofastJIY · Traditional | 11/24/1986SE |
| K863102 | Glucometer-ECGA · Traditional | 11/24/1986SE |
Questions and answers
When was HDL Cholesterol-E cleared by the FDA?
HDL Cholesterol-E (K863065) received a 510(k) decision of Substantially Equivalent on September 25, 1986, 44 days after the submission was received.