510(k) K822298
K822298 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI". The FDA issued a decision of Substantially Equivalent on Sep 2, 1982. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Nuclear Medical Laboratories, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 2, 1982
- Date Received
- Aug 3, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Acid Phosphatase (Prostatic), Tartrate Inhibited
- Device Class
- Class II
- Regulation Number
- 862.1020
- Review Panel
- CH
- Submission Type
- 510(k) Exempt