Submission Details
| 510(k) Number | K981425 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 16, 1998 |
| Decision Date | May 12, 1998 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
Cleared
Traditional
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
May 1998
Decision
26d
Days
Class 2
Risk
About This 510(k) Submission
K981425 is an FDA 510(k) clearance for the STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS, a Instrument, Hematocrit, Automated (Class II — Special Controls, product code GKF), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on May 12, 1998, 26 days after receiving the submission on April 16, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 864.5600.
Device Classification
| Product Code | GKF — Instrument, Hematocrit, Automated |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5600 |
Manufacturer
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