K952501 is an FDA 510(k) clearance for the TOX PERFECT B TUBES AND REAGENTS. This device is classified as a Columns, Liquid Chromatography (Class I - General Controls, product code DPM).
Submitted by Chimera Research & Chemical, Inc. (Seminole, US). The FDA issued a Cleared decision on August 24, 1995, 86 days after receiving the submission on May 30, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2260.
| 510(k) Number | K952501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1995 |
| Decision Date | August 24, 1995 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DPM — Columns, Liquid Chromatography |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2260 |