IDZClass I
Cassettes, Tissue
21 CFR 864.3010 / Pathology
IDZ is the FDA product code for Cassettes, Tissue, a class I device type, regulated under 21 CFR 864.3010. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- IDZ
- Device name
- Cassettes, Tissue
- Regulation
- 21 CFR 864.3010
- Device class
- Class I
- Review panel
- Pathology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 1
Clearances, product code IDZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1983 | 2 |
| 1986 | 2 |
Applicants with the most clearances
Product code IDZ| Applicant | Clearances |
|---|---|
| Surgipath Medical Industries, Inc. | 2 |
| Australian Biomedical Corporation, Ltd. | 1 |
| Polymer Technology Corp. | 1 |
| Sherwood Medical Industries | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- A Fone Surgico
- Acot Plastics (Xiamen) Co., Ltd.
- Agilent Technologies Singapore (International) Pte Ltd.
- Bach Viet Plastic
- Belair Instrument Co, LLC D/B/a Avantik
- Boen Healthcare Co., Ltd.
- Cancer Diagnostics, Inc.
- Cellpath Ltd
- Chemex Industrial Co., Ltd.
- CITOTEST Labware Manufacturing CO., Ltd.
- Citotest Scientific Co.,Ltd.
- Creative Waste Solutions, Inc.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
