K944227 is an FDA 510(k) clearance for the ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER. This device is classified as a Instrument, Coagulation, Automated (Class II - Special Controls, product code GKP).
Submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on February 3, 1995, 155 days after receiving the submission on September 1, 1994.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5400.
| 510(k) Number | K944227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1994 |
| Decision Date | February 03, 1995 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKP — Instrument, Coagulation, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5400 |