BIO-PEN CALCULATOR
FDA 510(k) clearance K860205 · decided 1986-04-24
Clearance details
- K-number
- K860205
- Device name
- BIO-PEN CALCULATOR
- Applicant
- Oculab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-22
- Decision date
- 1986-04-24
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- LQB
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Gendale, CA, 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 |
|---|---|---|
| BIO-PEN SRK II CALCULATOR (K922590) | Bio-Rad | 1993-08-03 |
Recalls involving this device
No recalls on record reference this clearance.