510(k) K922590
- Device
- Bio-pen Srk Ii Calculator
- Applicant
- BIO-RAD
- 510(k) number
- K922590
- Product code
- LQB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-08-03
- Date received
- 1992-06-02
- Classification name
- Medical Computers And Software For Ophthalmic Use
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- 3
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD TEASDALE
- Address
- 635 W. Colorado St. Glendale CA US 91204 91204
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LQB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K860205 | BIO-PEN CALCULATOR | Oculab, Inc. | 1986-04-24 |