510(k) K951848
K951848 is an FDA 510(k) premarket notification submitted by Tosoh Medics, Inc. for the device "AIA-PACK CPR ASSAY". The FDA issued a decision of Substantially Equivalent on February 13, 1996. The device falls under product code JKD (Radioimmunoassay, C-Peptides Of Proinsulin), a Class I device regulated under 21 CFR 862.1135. Tosoh Medics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1996
- Date Received
- April 21, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, C-Peptides Of Proinsulin
- Device Class
- Class I
- Regulation Number
- 862.1135
- Review Panel
- CH
- Submission Type