510(k) K895160
- Device
- ORTHO *APO A-1 ELISA TEST SYSTEM
- Applicant
- MEDICAL MARKETING CONSULTANTS, INC.
- 510(k) number
- K895160
- Product code
- DEL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-06
- Date received
- 1989-08-23
- 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
- JOYCE DAVIS
- Address
- 3 Bethesda Metro Center Suite 750 Bethesda MD US 20814 20814
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 |
| K900124 | APOLIPOPROTEIN B (APO B) | Sigma Chemical Co. | 1990-03-02 |
| K893885 | BACTON TM, BASIC TM, APO A-I REAGENT | Catachem, Inc. | 1989-06-21 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases