TINA-QUANT APOLIPOPROTEIN A-1 VER.2
FDA 510(k) clearance K013278 · decided 2001-11-15
Clearance details
- K-number
- K013278
- Device name
- TINA-QUANT APOLIPOPROTEIN A-1 VER.2
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-01
- Decision date
- 2001-11-15
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- DEL
- Device class
- 1
- Regulation number
- 866.5590
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| APOLIPOPROTEIN A-I (APO A-I) (K901675) | Sigma Chemical Co. | 1990-04-26 |
| APOLIPOPROTEIN B (APO B) (K900124) | Sigma Chemical Co. | 1990-03-02 |
| ORTHO *APO A-1 ELISA TEST SYSTEM (K895160) | Medical Marketing Consultants, Inc. | 1989-10-06 |
| BACTON TM, BASIC TM, APO A-I REAGENT (K893885) | Catachem, Inc. | 1989-06-21 |
Recalls involving this device
No recalls on record reference this clearance.
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