Plastinex
510(k) K852484
Plastinex is a Class II device made by Bio/Data Corp., cleared under FDA 510(k) K852484 on 12 Aug 1985, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852484 | Date12 Aug 1985 | StatusActive |
Official records
- FDA 510(k) database K852484
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GJS
- Device class
- Class II
- Regulation
- 21 CFR Part 864.7750
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
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- NYCOPLASTIN by Nycomed Pharma AS
- HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT by International Technidyne Corp.
- THROMBOREL S by Behring Diagnostics, Inc.
- VISION(R) PROTHROMBIN TIME by Abbott Laboratories
- microINR System by Iline Microsystems, S.L.
- PROTHROMBIN TIME TEST CARD by Cardiovascular Diagnostics, Inc.
- DADE THROMBOPLASTIN C PLUS by Dade Behring, Inc.