Reptilase -Pc
510(k) K843207
Reptilase -Pc is a Class II device made by Bio/Data Corp., cleared under FDA 510(k) K843207 on 23 Oct 1984, active as of 12 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 | NumberK843207 | Date23 Oct 1984 | StatusActive |
Official records
- FDA 510(k) database K843207
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JCO
- Device class
- Class II
- Regulation
- 21 CFR Part 864.8100
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
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