510(k) K811805
K811805 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "TRYPIN (125I) RIA KIT". The FDA issued a decision of Substantially Equivalent on August 31, 1981. The device falls under product code JNO (N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin), a Class I device regulated under 21 CFR 862.1725. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1981
- Date Received
- June 24, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
- Device Class
- Class I
- Regulation Number
- 862.1725
- Review Panel
- CH
- Submission Type