510(k) K844965
K844965 is an FDA 510(k) premarket notification submitted by Alladin Diagnostic, Inc. for the device "LEUCINE AMINOPEPTIDASE REAGENT". The FDA issued a decision of Substantially Equivalent on March 5, 1985. The device falls under product code JGG (L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase), a Class I device regulated under 21 CFR 862.1460. Alladin Diagnostic, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1985
- Date Received
- December 24, 1984
- 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