Submission Details
| 510(k) Number | K802422 FDA.gov |
| FDA Decision | Cleared SESP |
| Date Received | October 06, 1980 |
| Decision Date | October 06, 1980 |
| Days to Decision | — |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
K802422 - HYCEL TRIGYCERIDE II TEST
(FDA 510(k) Clearance)
Oct 1980
Decision
—
Days
—
Risk
K802422 is an FDA 510(k) clearance for the HYCEL TRIGYCERIDE II TEST, submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1980. This device falls under the Chemistry review panel.
Device Classification
| Product Code | — |
| Device Class | — |