Ortho *Apo A-1 Elisa Test System
FDA 510(k) K895160 · Medical Marketing Consultants, Inc.
510(k) numberK895160
Submission
- Device name
- Ortho *Apo A-1 Elisa Test System
- Applicant
- Medical Marketing Consultants, Inc.
Bethesda, MD, US - Received
- August 23, 1989
- Decision date
- October 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEL – Lipoprotein X, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5590
- Specialty
- Immunology
Other 510(k)s with product code DEL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013278 | Tina-Quant Apolipoprotein A-1 VER.2DEL · Traditional | Roche Diagnostics Corp. | 11/15/2001SE |
| K901675 | Apolipoprotein A-I (Apo A-I)DEL · Traditional | Sigma Chemical Co. | 04/26/1990SE |
| K900124 | Apolipoprotein B (Apo B)DEL · Traditional | Sigma Chemical Co. | 03/02/1990SE |
| K893885 | Bacton TM, Basic TM, Apo A-I ReagentDEL · Traditional | Catachem, Inc. | 06/21/1989SE |
More from Catachem, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K895277 | Ortho Apo B Elisa Test SystemMSJ · Traditional | 09/27/1989SE |
Questions and answers
When was Ortho *Apo A-1 Elisa Test System cleared by the FDA?
Ortho *Apo A-1 Elisa Test System (K895160) received a 510(k) decision of Substantially Equivalent on October 6, 1989, 44 days after the submission was received.
What is the product code of K895160?
The FDA product code is DEL – Lipoprotein X, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5590.