K781376 is an FDA 510(k) clearance for the STANDARDIZE TGCL & TGCH. This device is classified as a Transport Systems, Anaerobic (Class I - General Controls, product code JTX).
Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1978, 36 days after receiving the submission on August 9, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K781376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1978 |
| Decision Date | September 14, 1978 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JTX — Transport Systems, Anaerobic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |