LIJ · Peroxidase Anti-Peroxidase Immunohistochemical Stain
Pathology · 21 CFR 864.4400 · Class 1
Overview
| Product Code | LIJ |
|---|---|
| Device Name | Peroxidase Anti-Peroxidase Immunohistochemical Stain |
| 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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K855034 | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT | Bartels Immunodiagnostic Supplies, Inc. | Mar 11, 1986 | SESE |
| K820336 | DAKO PAP KIT K509 | Dako Corp. | Jul 13, 1982 | SESE |
Top Applicants
- Dako Corp. — 1 clearance
- Bartels Immunodiagnostic Supplies, Inc. — 1 clearance
