AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
Device Facts
| Record ID | K855034 |
|---|---|
| Device Name | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT |
| Applicant | Bartels Immunodiagnostic Supplies, Inc. |
| Product Code | LIJ · Pathology |
| Decision Date | Mar 11, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.4400 |
| Device Class | Class 1 |
Regulatory Classification
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).
