AUTOMATED ENZYME
Device Facts
| Record ID | K780962 |
|---|---|
| Device Name | AUTOMATED ENZYME |
| Applicant | Hyland Therapeutic Div., Travenol Laboratories |
| Product Code | KSK · Hematology |
| Decision Date | Jul 27, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A stabilized enzyme solution is a reagent intended for medical purposes that is used to enhance the reactivity of red blood cells with certain antibodies, including antibodies that are not detectable by other techniques. These enzyme solutions include papain, bromelin, ficin, and trypsin.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
