B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
FDA 510(k) clearance K070310 · decided 2008-03-31
Clearance details
- K-number
- K070310
- Device name
- B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
- Applicant
- Brahms Aktiengesellschaft
- Decision
- Substantially Equivalent
- Date received
- 2007-02-01
- Decision date
- 2008-03-31
- Days to decision
- 424 days
- Clearance type
- Traditional
- Product code
- NTM
- Device class
- 2
- Regulation number
- 866.3210
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Annapolis, MD, 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 |
|---|---|---|
| VIDAS B.R.A.H.M.S. PCT ASSAY (K071146) | bioMerieux, Inc. | 2007-10-11 |
| B-R-A-H-M-S PCT LIA (K040887) | Brahms Aktiengesellschaft | 2005-01-07 |
Recalls involving this device
No recalls on record reference this clearance.