FDA product code IDZ: Cassettes, Tissue
IDZ is the FDA product code for cassettes, tissue. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. FDA has cleared 5 510(k) submissions under IDZ, from 4 different applicants. The average 510(k) review took 18 days (median 16). FDA has posted 1 recall for IDZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Cassettes, Tissue |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IDZ clearance
Top IDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgipath Medical Industries, Inc. | 2 | 1986-09-16 |
| Australian Biomedical Corporation , Ltd. | 1 | 1986-07-16 |
| Polymer Technology Corp. | 1 | 1983-12-02 |
| Sherwood Medical Industries | 1 | 1976-09-27 |
Most recent IDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863483 | Surgipath Medical Industries, Inc. | CASSETTE EMBOSSEER | 1986-09-16 | 7 |
| K862457 | Australian Biomedical Corporation , Ltd. | LYNX EL MICROSCOPY TISSUE PROCESSOR | 1986-07-16 | 16 |
| K833857 | Polymer Technology Corp. | MACLEAN-FOGG, TISSUE CASSETTES | 1983-12-02 | 25 |
| K831334 | Surgipath Medical Industries, Inc. | TISSUE CASSETTES FOR PROCESSING-EM BED | 1983-05-25 | 30 |
| K760623 | Sherwood Medical Industries | LANCER PARAPLAST HISTO PROCESS CASSETTE | 1976-09-27 | 14 |
Recalls for IDZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-04-04.
Frequently asked questions
What is FDA product code IDZ?
IDZ is the FDA product code for cassettes, tissue. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDZ?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IDZ?
Across 5 cleared submissions the average was 18 days from receipt to decision (median 16).
Which companies have the most IDZ clearances?
Surgipath Medical Industries, Inc. (2); Australian Biomedical Corporation , Ltd. (1); Polymer Technology Corp. (1); Sherwood Medical Industries (1).
Have IDZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-04-04.
Next steps
- Run an FDA pathway report with predicate devices for product code IDZ
- Run a recall and safety report across every IDZ manufacturer
- Watch product code IDZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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