510(k) K871903
K871903 is an FDA 510(k) premarket notification submitted by Creative Scientific Technology, Inc. for the device "QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL)". The FDA issued a decision of Substantially Equivalent on September 2, 1987. The device falls under product code JFN (Atomic Absorption, Calcium), a Class II device regulated under 21 CFR 862.1145.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 1987
- Date Received
- May 15, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Atomic Absorption, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type