510(k) K895850
K895850 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "SYNCHRON CX SYSTEMS (LAP) REAGENT KIT". The FDA issued a decision of Substantially Equivalent on December 5, 1989. The device falls under product code JGG (L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase), a Class I device regulated under 21 CFR 862.1460. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1989
- Date Received
- October 3, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
- Device Class
- Class I
- Regulation Number
- 862.1460
- Review Panel
- CH
- Submission Type