510(k) K963551
K963551 is an FDA 510(k) premarket notification submitted by Biocell Laboratories, Inc. for the device "BIO-CSF LIQUID CONTROL LEVEL 1 AND 2". The FDA issued a decision of Substantially Equivalent on Oct 7, 1996. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Biocell Laboratories, Inc. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 7, 1996
- Date Received
- Sep 5, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type
- 510(k) Exempt