BIOMIC VIDEO PLATE READER
FDA 510(k) clearance K932122 · decided 1994-03-01
Clearance details
- K-number
- K932122
- Device name
- BIOMIC VIDEO PLATE READER
- Applicant
- Giles Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-03
- Decision date
- 1994-03-01
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- KZK
- Device class
- 1
- Regulation number
- 866.2850
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- New York, NY, 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 |
|---|---|---|
| SIRSCAN (K991473) | Intelligence Artificielle Applications | 1999-11-23 |
| BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM (K944319) | Giles Scientific, Inc. | 1994-12-15 |
Recalls involving this device
No recalls on record reference this clearance.