Apolipoprotein B (Apo B)
FDA 510(k) K900124 · Sigma Chemical Co.
510(k) numberK900124
Submission
- Device name
- Apolipoprotein B (Apo B)
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- January 9, 1990
- Decision date
- March 2, 1990
- 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 |
| 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 |
More from Catachem, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933694 | Sigma Glucose ReagentCGA · Traditional | 11/04/1994SE |
| K933678 | Sigma Calcium ReagentCJY · Traditional | 03/11/1994SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
Questions and answers
When was Apolipoprotein B (Apo B) cleared by the FDA?
Apolipoprotein B (Apo B) (K900124) received a 510(k) decision of Substantially Equivalent on March 2, 1990, 52 days after the submission was received.
What is the product code of K900124?
The FDA product code is DEL – Lipoprotein X, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5590.