510(k) K843382
K843382 is an FDA 510(k) premarket notification submitted by Mission Pharmacal Co. for the device "UROCYSTIN". The FDA issued a decision of Substantially Equivalent on January 8, 1985. The device falls under product code JLC (Nitroprusside Reaction (Qualitative, Urine), Cystine), a Class I device regulated under 21 CFR 862.1240. Mission Pharmacal Co. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 1985
- Date Received
- August 28, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nitroprusside Reaction (Qualitative, Urine), Cystine
- Device Class
- Class I
- Regulation Number
- 862.1240
- Review Panel
- CH
- Submission Type