K894389 is an FDA 510(k) clearance for the CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS. This device is classified as a Pipette, Sahli (Class I - General Controls, product code GGX).
Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on October 12, 1989, 87 days after receiving the submission on July 17, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.6160.
| 510(k) Number | K894389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1989 |
| Decision Date | October 12, 1989 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | GGX — Pipette, Sahli |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.6160 |