Submission Details
| 510(k) Number | K880794 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
RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL
Apr 1988
Decision
52d
Days
Class 2
Risk
About This 510(k) Submission
K880794 is an FDA 510(k) clearance for the RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), 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 862.1160.
Device Classification
| Product Code | KHS — Enzymatic, Carbon-dioxide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1160 |
Manufacturer
Similar Devices — KHS Enzymatic, Carbon-dioxide
All 85
K170200 · Teco Diagnostics, Inc.
· Jun 2017
K152085 · Randox Laboratories, Ltd.
· Feb 2016
K140248 · Hitachi Chemical Diagnostics, Inc.
· Mar 2014
K131546 · Beckman Coulter Ireland, Inc.
· Oct 2013
K123953 · Alfa Wassermann Diagnostic Technologies, Inc.
· May 2013
K120765 · Ortho-Clinical Diagnostics, Inc.
· Oct 2012
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