Photron Visual Field Analyzer
FDA 510(k) K860642 · Biosan Laboratories, Inc.
510(k) numberK860642
Submission
- Device name
- Photron Visual Field Analyzer
- Applicant
- Biosan Laboratories, Inc.
San Rafael, CA, US - Received
- February 20, 1986
- Decision date
- April 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOM – Screen, Tangent, Ac-Powered (Campimeter)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1810
- Specialty
- Ophthalmic
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| 510(k) | Device | Decision |
|---|---|---|
| K853812 | Photron Neurovisual Stimulator(Modification)HLX · Traditional | 11/01/1985SE |
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| K833193 | Radioimmunoassay, Thyroid Stimu. HormoneJLW · Traditional | 02/04/1984SE |
| K834023 | Bio-Science Laboratories T4 ReagentCDX · Traditional | 01/24/1984SE |
| K833318 | Normal Goat SerumDHX · Traditional | 01/03/1984SE |
| K833320 | Amberlite CG50 Resin, 100-200 MeshKEA · Traditional | 12/08/1983SE |
| K833192 | Normal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833191 | Abnormal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833319 | Bio-Rex 70 Resin 100-200 Mesh PH6.2KEA · Traditional | 11/03/1983SE |
Questions and answers
When was Photron Visual Field Analyzer cleared by the FDA?
Photron Visual Field Analyzer (K860642) received a 510(k) decision of Substantially Equivalent on April 15, 1986, 54 days after the submission was received.
What is the product code of K860642?
The FDA product code is HOM – Screen, Tangent, Ac-Powered (Campimeter), a Class I (low risk) device regulated under 21 CFR 886.1810.