N LATEX CDT
FDA 510(k) clearance K060677 · decided 2006-08-25
Clearance details
- K-number
- K060677
- Device name
- N LATEX CDT
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-14
- Decision date
- 2006-08-25
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- NAO
- Device class
- 1
- Regulation number
- 862.1360
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dade Behring
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY (K001943) | Sangui Biotech, Inc. | 2000-08-23 |
| AXIS %CDT TURBIDIMETRIC IMMUNOASSAY (K992502) | Axis | 1999-12-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003) | Dade Behring, Inc. | 2002-07-24 |
| COBAS INTEGRA CYCLOSPORINE (P920031/S002) | Dade Behring, Inc. | 2002-02-26 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001) | Dade Behring, Inc. | 2000-08-11 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031) | Dade Behring, Inc. | 1996-10-02 |