Submission Details
| 510(k) Number | K981426 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 | Hematology (HE) |
| Summary | Statement |
Cleared
Traditional
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
May 1998
Decision
26d
Days
Class 2
Risk
About This 510(k) Submission
K981426 is an FDA 510(k) clearance for the STAT PROFILE ULTRA F,G,H,I,J,K, AND L 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 Hematology 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
Similar Devices — GKF Instrument, Hematocrit, Automated
All 14
K160415 · Instrumentation Laboratory CO
· Dec 2016
K983551 · In-Line Diagnostics Corp.
· May 1999
K981425 · Nova Biomedical Corp.
· May 1998
K981427 · Nova Biomedical Corp.
· May 1998
K953519 · Vulcon Technologies
· Nov 1995
K915825 · Fisher Scientific Co., LLC
· Mar 1992
More from Nova Biomedical Corp.
View all
K100602
· KHP · Aug 2011
K101633
· JJY · Aug 2010
K091547
· NBW · Jan 2010
K070960
· CGA · Jul 2007
K070255
· NBW · Jun 2007