21 CFR 886.1800 — Strip, Schirmer
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1800
Identification
A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to stimulate and evaluate formation of tears.
Classification Rationale
Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KYD | Strip, Schirmer | 1 | 3 |
