Submission Details
| 510(k) Number | K880796 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 1988 |
| Decision Date | April 18, 1988 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
ALKALINE PHOSPHATASE REAGENT, DEA BUFF
Apr 1988
Decision
52d
Days
Class 2
Risk
About This 510(k) Submission
K880796 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE REAGENT, DEA BUFF, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on April 18, 1988, 52 days after receiving the submission on February 26, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.
Device Classification
| Product Code | CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1050 |
Manufacturer
Similar Devices — CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
All 123
K251074 · Truvian Health
· Dec 2025
K240468 · Abbott Laboratories Diagnostics Division
· Oct 2024
K223317 · Abbott Ireland Diagnostics Division
· Jul 2023
K191245 · HORIBA ABX SAS
· Aug 2019
K171971 · Lite-On Technology Corp. H.S.P.B.
· Jan 2018
K171080 · Roche Diagnostics Operations (Rdo)
· May 2017
More from Trace America, Inc.
View all
K003583
· NDW · Jan 2001
K980026
· CFR · Mar 1998
K980028
· CKA · Feb 1998
K980030
· CIT · Jan 1998
K973869
· CKA · Jan 1998