MRSA-SCREEN
FDA 510(k) clearance K011400 · decided 2002-03-27
Clearance details
- K-number
- K011400
- Device name
- MRSA-SCREEN
- Applicant
- Denka Seiken'S
- Decision
- Substantially Equivalent
- Date received
- 2001-05-07
- Decision date
- 2002-03-27
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- MYI
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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| MASTALEX -MRSA, MODEL RST501 (K062864) | Mast Group , Ltd. | 2006-10-18 |
| OXOID PBP2 1 LATEX AGGLUTINATION TEST (K011710) | Oxoid , Ltd. | 2002-04-02 |
| VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION (K010858) | Id Biomedical Corp. | 2001-05-24 |
| VELOGENE RAPID MRSA IDENTIFICATION ASSAY (K990640) | Id Biomedical Corp. | 1999-07-09 |
Recalls involving this device
No recalls on record reference this clearance.