510(k) K791202
K791202 is an FDA 510(k) premarket notification submitted by Cis Radiopharmaceuticals, Inc. for the device "RIA KIT FOR TRYPSIN". The FDA issued a decision of Substantially Equivalent on November 5, 1979. 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. Cis Radiopharmaceuticals, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1979
- Date Received
- June 28, 1979
- 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