CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
FDA 510(k) clearance K954997 · decided 1996-01-24
Clearance details
- K-number
- K954997
- Device name
- CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
- Applicant
- Centocor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-01
- Decision date
- 1996-01-24
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JOZ
- Device class
- 2
- Regulation number
- 864.5700
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Malvern, PA, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CA 125 ANTIBODY RIA (P850009/S007) | Centocor, Inc. | 1994-12-21 |
| CA 125 ANTIBODY RIA (P850009/S006) | Centocor, Inc. | 1994-03-23 |
| CA 125 ANTIBODY RIA (P850009/S005) | Centocor, Inc. | 1992-07-15 |
| CA 125 ANTIBODY RIA (P850009/S004) | Centocor, Inc. | 1991-03-28 |
| CA 125 ANTIBODY RIA (P850009/S002) | Centocor, Inc. | 1990-02-13 |
| CA 125 ANTIBODY RIA (P850009/S001) | Centocor, Inc. | 1987-07-28 |