510(k) K022603
K022603 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER". The FDA issued a decision of Substantially Equivalent on Aug 21, 2002. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Diagnostic Products Corp. has 320 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 21, 2002
- Date Received
- Aug 6, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Parathyroid Hormone
- Device Class
- Class II
- Regulation Number
- 862.1545
- Review Panel
- CH
- Submission Type
- 510(k)