TECHNICON RA-1000 SYS, ANALYTES III
FDA 510(k) clearance K821514 · decided 1982-05-10
Clearance details
- K-number
- K821514
- Device name
- TECHNICON RA-1000 SYS, ANALYTES III
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-10
- Decision date
- 1982-05-10
- Days to decision
- 0 days
- Clearance type
- Traditional
- Product code
- JEJ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- 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 |
|---|---|---|
| EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 (K874705) | Em Diagnostic Systems, Inc. | 1987-12-22 |
Recalls involving this device
No recalls on record reference this clearance.