K861741 is an FDA 510(k) clearance for the TDX REA LACTIC ACID. This device is classified as a Acid, Lactic, Enzymatic Method (Class I - General Controls, product code KHP).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 7, 1986, 62 days after receiving the submission on May 6, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1450.
| 510(k) Number | K861741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1986 |
| Decision Date | July 07, 1986 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KHP — Acid, Lactic, Enzymatic Method |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1450 |