HEMOCCULT SENSITIVE TEST
Device Facts
| Record ID | K880499 |
|---|---|
| Device Name | HEMOCCULT SENSITIVE TEST |
| Applicant | Smithkline Diagnostics, Inc. |
| Product Code | KHE · Hematology |
| Decision Date | May 23, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.6550 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
Special Controls
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
