510(k) K013278
- Device
- TINA-QUANT APOLIPOPROTEIN A-1 VER.2
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K013278
- Product code
- DEL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-15
- Date received
- 2001-10-01
- Regulation
- 866.5590
- Classification name
- Lipoprotein X, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HELEN TORNEY
- Address
- 9115 Hague Rd. Indianapolis IN US 46256 46256
FDA Registration Numbers#
- 9610529
- 2029372
- 9610126
- 3006198300
- 3003795116
Source Documents#
Other 510(k) Records For Product Code DEL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901675 | APOLIPOPROTEIN A-I (APO A-I) | Sigma Chemical Co. | 1990-04-26 |
| K900124 | APOLIPOPROTEIN B (APO B) | Sigma Chemical Co. | 1990-03-02 |
| 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#
summary
FDA Review#
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