SIRSCAN
FDA 510(k) clearance K991473 · decided 1999-11-23
Clearance details
- K-number
- K991473
- Device name
- SIRSCAN
- Applicant
- Intelligence Artificielle Applications
- Decision
- Substantially Equivalent
- Date received
- 1999-04-27
- Decision date
- 1999-11-23
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- KZK
- Device class
- 1
- Regulation number
- 866.2850
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Washington, DC, 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 |
|---|---|---|
| BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM (K944319) | Giles Scientific, Inc. | 1994-12-15 |
| BIOMIC VIDEO PLATE READER (K932122) | Giles Scientific, Inc. | 1994-03-01 |
Recalls involving this device
No recalls on record reference this clearance.