Tina-Quant Apolipoprotein A-1 VER.2
FDA 510(k) K013278 · Roche Diagnostics Corp.
510(k) numberK013278
Submission
- Device name
- Tina-Quant Apolipoprotein A-1 VER.2
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- October 1, 2001
- Decision date
- November 15, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K895160 | Ortho *Apo A-1 Elisa Test SystemDEL · Traditional | Medical Marketing Consultants, Inc. | 10/06/1989SE |
| K893885 | Bacton TM, Basic TM, Apo A-I ReagentDEL · Traditional | Catachem, Inc. | 06/21/1989SE |
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Questions and answers
When was Tina-Quant Apolipoprotein A-1 VER.2 cleared by the FDA?
Tina-Quant Apolipoprotein A-1 VER.2 (K013278) received a 510(k) decision of Substantially Equivalent on November 15, 2001, 45 days after the submission was received.
What is the product code of K013278?
The FDA product code is DEL – Lipoprotein X, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5590.