CALCIUM/MAGNESIUM ANALYZER
FDA 510(k) clearance K770570 · decided 1977-06-08
Clearance details
- K-number
- K770570
- Device name
- CALCIUM/MAGNESIUM ANALYZER
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-03-25
- Decision date
- 1977-06-08
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- JFN
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY (K914510) | Beckman Instruments, Inc. | 1991-11-19 |
| QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL) (K871903) | Creative Scientific Technology, Inc. | 1987-09-02 |
Recalls involving this device
No recalls on record reference this clearance.