510(k) K905215
K905215 is an FDA 510(k) premarket notification submitted by Cirrus Diagnostics, Inc. for the device "IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER". The FDA issued a decision of Substantially Equivalent on January 11, 1991. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Cirrus Diagnostics, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1991
- Date Received
- November 20, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2300
- Review Panel
- CH
- Submission Type