Bio-Pen SRK II Calculator
FDA 510(k) K922590 · Bio-Rad
510(k) numberK922590
Submission
- Device name
- Bio-Pen SRK II Calculator
- Applicant
- Bio-Rad
Glendale, CA, US - Received
- June 2, 1992
- Decision date
- August 3, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LQB – Medical Computers And Software For Ophthalmic Use
- Device class
- Class III (high risk)
Other 510(k)s with product code LQB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K860205 | Bio-Pen CalculatorLQB · Traditional | Oculab, Inc. | 04/24/1986SE |
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Questions and answers
When was Bio-Pen SRK II Calculator cleared by the FDA?
Bio-Pen SRK II Calculator (K922590) received a 510(k) decision of Substantially Equivalent on August 3, 1993, 427 days after the submission was received.
What is the product code of K922590?
The FDA product code is LQB – Medical Computers And Software For Ophthalmic Use, a Class III (high risk) device.