510(k) K961984
K961984 is an FDA 510(k) premarket notification submitted by Trace America, Inc. for the device "PORPHOBILINOGEN (PBG)". The FDA issued a decision of Substantially Equivalent on December 10, 1996. The device falls under product code JNF (Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen), a Class I device regulated under 21 CFR 862.1590. Trace America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1996
- Date Received
- May 21, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
- Device Class
- Class I
- Regulation Number
- 862.1590
- Review Panel
- CH
- Submission Type