510(k) K900124
- Device
- APOLIPOPROTEIN B (APO B)
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K900124
- Product code
- DEL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-02
- Date received
- 1990-01-09
- Regulation
- 866.5590
- Classification name
- Lipoprotein X, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MATHEW MADAPPALLY
- Address
- 545 S. Ewing Ave. St. Louis MO US 63103 63103
FDA Registration Numbers#
- 9610126
- 9610529
- 3006198300
- 2029372
- 3003795116
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DEL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013278 | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 | Roche Diagnostics Corp. | 2001-11-15 |
| K901675 | APOLIPOPROTEIN A-I (APO A-I) | Sigma Chemical Co. | 1990-04-26 |
| K895160 | ORTHO *APO A-1 ELISA TEST SYSTEM | Medical Marketing Consultants, Inc. | 1989-10-06 |
| K893885 | BACTON TM, BASIC TM, APO A-I REAGENT | Catachem, Inc. | 1989-06-21 |
Legacy Summary#
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FDA Review#
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