TROPONIN-I TEST SYSTEM
FDA 510(k) clearance K964862 · decided 1997-02-10
Clearance details
- K-number
- K964862
- Device name
- TROPONIN-I TEST SYSTEM
- Applicant
- Dade Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-04
- Decision date
- 1997-02-10
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS (P870049/S032) | Dade Intl., Inc. | 2001-11-30 |
| MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S031) | Dade Intl., Inc. | 2001-11-09 |
| MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S030) | Dade Intl., Inc. | 2000-06-05 |
| MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S029) | Dade Intl., Inc. | 1999-06-24 |
| MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S028) | Dade Intl., Inc. | 1999-01-25 |
| MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S027) | Dade Intl., Inc. | 1998-06-30 |
| MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS (P870049/S025) | Dade Intl., Inc. | 1996-05-03 |
| MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S024) | Dade Intl., Inc. | 1996-03-12 |