HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
FDA 510(k) clearance K970396 · decided 1997-02-20
Clearance details
- K-number
- K970396
- Device name
- HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
- Applicant
- Dade Chemistry Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-02-03
- Decision date
- 1997-02-20
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- JIW
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Glasgow, DE, US
- Third-party review
- No
- Expedited review
- No
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| CALIBRATION KIT (K882220) | King Diagnostics, Inc. | 1988-08-02 |
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| UNIMETER CALIBRATION KIT (K880610) | Boehringer Mannheim Corp. | 1988-03-24 |
| AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER (K854028) | Verified Medical Research, Inc. | 1985-12-02 |
| FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM (K851450) | Flow Cytometry Standards Corp. | 1985-09-16 |
| QUICK-CHEM CALIBRATION SET (K852260) | Seragen Diagnostics, Inc. | 1985-07-22 |
Recalls involving this device
No recalls on record reference this clearance.