ELECSYS CALLCHECK DIGOXIN
FDA 510(k) clearance K973973 · decided 1997-11-04
Clearance details
- K-number
- K973973
- Device name
- ELECSYS CALLCHECK DIGOXIN
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-20
- Decision date
- 1997-11-04
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DMP
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Pleasanton, CA, 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 |
|---|---|---|
| TOX PERFECT A TUBE (K953393) | Chimera Research & Chemical, Inc. | 1995-10-06 |
| DIGOXIN STANDARDS IN HUMAN SERUM (K780889) | Pcl-Ria, Inc. | 1978-08-14 |
| DIGI TROL TM-RX & DIGI TROL TM-TX (K770411) | Nuclear Medical Laboratories, Inc. | 1977-03-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |