510(k) K860205
- Device
- BIO-PEN CALCULATOR
- Applicant
- OCULAB, INC.
- 510(k) number
- K860205
- Product code
- LQB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-24
- Date received
- 1986-01-22
- Regulation
- 510(k) Premarket Notification
- Classification name
- Medical Computers And Software For Ophthalmic Use
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ophthalmic
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD W TEASDALE
- Address
- 443 W. Colorado St. Gendale 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 |
|---|---|---|---|
| K922590 | BIO-PEN SRK II CALCULATOR | Bio-Rad | 1993-08-03 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases