SYSTEMATE CALCIUM TEST TECHNICON RA 1000
FDA 510(k) clearance K922953 · decided 1992-09-09
Clearance details
- K-number
- K922953
- Device name
- SYSTEMATE CALCIUM TEST TECHNICON RA 1000
- Applicant
- Em Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-18
- Decision date
- 1992-09-09
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- CIL
- Device class
- 2
- Regulation number
- 862.1160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Gibbstown, NJ, 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 |
|---|---|---|
| PANCREATIC A-AMYLASE EPS (K895880) | Boehringer Mannheim Corp. | 1989-12-19 |
| ENZYMATIC CO2 (K833724) | American Monitor Corp. | 1983-12-29 |
| CO2 CONTENT (K800111) | American Monitor Corp. | 1980-02-13 |
Recalls involving this device
No recalls on record reference this clearance.