IBG · Trypsin
Pathology · 21 CFR 864.4400 · Class 1
Overview
| Product Code | IBG |
|---|---|
| Device Name | Trypsin |
| Regulation | 21 CFR 864.4400 |
| Device Class | Class 1 |
| Review Panel | Pathology |
Identification
Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:(1) To disaggregate tissues and cells already in established cultures for preparation into subsequent cultures (e.g., trypsin); (2) To disaggregate fluid specimens for cytological examination (e.g., papain for gastric lavage or trypsin for sputum liquefaction); (3) To aid in the selective staining of tissue specimens (e.g., diastase for glycogen determination).
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K802493 | SPUTASOL | Oxoid U.S.A., Inc. | Nov 12, 1980 | SESE |
| K771955 | TRYPSIN 1% | Flow Laboratories, Inc. | Nov 22, 1977 | SESE |
Top Applicants
- Flow Laboratories, Inc. — 1 clearance
- Oxoid U.S.A., Inc. — 1 clearance
