TISSUE PROCESSING CASSETTES & ACCESS
FDA 510(k) clearance K813430 · decided 1981-12-29
Clearance details
- K-number
- K813430
- Device name
- TISSUE PROCESSING CASSETTES & ACCESS
- Applicant
- American Optical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-08
- Decision date
- 1981-12-29
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- IDL
- Device class
- 1
- Regulation number
- 864.3010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KNIFE MAKER (K863616) | Surgipath Medical Industries, Inc. | 1986-09-25 |
| DISPOSABLE MICROTOME BLADES (K831921) | Polymer Technology Corp. | 1983-07-29 |
| DISPOSABLE MICROTOME BLADE (K831308) | Surgipath Medical Industries, Inc. | 1983-05-16 |
| TISSUE-TEK III MICROJECT DISP. BLADE SYS (K801426) | Miles Laboratories, Inc. | 1980-07-28 |
Recalls involving this device
No recalls on record reference this clearance.