510(k) K844344
K844344 is an FDA 510(k) premarket notification submitted by Biocell Laboratories, Inc. for the device "GEMCAL ENI REFERENCE SERUM". The FDA issued a decision of Substantially Equivalent on Jan 3, 1985. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Biocell Laboratories, Inc. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 3, 1985
- Date Received
- Nov 9, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Calibrator, Multi-Analyte Mixture
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type
- 510(k) Exempt