The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Ultra F,g,h,i,j,k, And L Analyzers.
| Device ID | K981426 |
| 510k Number | K981426 |
| Device Name: | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS |
| Classification | Instrument, Hematocrit, Automated |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | GKF |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHL |
| Subsequent Product Code | GKR |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJS |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 864.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-16 |
| Decision Date | 1998-05-12 |