TISSUE CASSETTES FOR PROCESSING-EM BED
FDA 510(k) clearance K831334 · decided 1983-05-25
Clearance details
- K-number
- K831334
- Device name
- TISSUE CASSETTES FOR PROCESSING-EM BED
- Applicant
- Surgipath Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-25
- Decision date
- 1983-05-25
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- IDZ
- 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 |
|---|---|---|
| CASSETTE EMBOSSEER (K863483) | Surgipath Medical Industries, Inc. | 1986-09-16 |
| LYNX EL MICROSCOPY TISSUE PROCESSOR (K862457) | Australian Biomedical Corporation , Ltd. | 1986-07-16 |
| MACLEAN-FOGG, TISSUE CASSETTES (K833857) | Polymer Technology Corp. | 1983-12-02 |
| LANCER PARAPLAST HISTO PROCESS CASSETTE (K760623) | Sherwood Medical Industries | 1976-09-27 |
Recalls involving this device
No recalls on record reference this clearance.