The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Critical Care Xpress (ccx), Model 1+.
| Device ID | K061830 |
| 510k Number | K061830 |
| Device Name: | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-28 |
| Decision Date | 2006-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385480427951 | K061830 | 000 |
| 10385480374139 | K061830 | 000 |
| 00385480371681 | K061830 | 000 |
| 00385480369213 | K061830 | 000 |
| 00385480367943 | K061830 | 000 |
| 00385480367868 | K061830 | 000 |
| 00385480364614 | K061830 | 000 |
| 00385480364591 | K061830 | 000 |
| 00385480364577 | K061830 | 000 |
| 00385480364553 | K061830 | 000 |
| 00385480364539 | K061830 | 000 |
| 00385480362597 | K061830 | 000 |
| 00385480362528 | K061830 | 000 |
| 00385480356381 | K061830 | 000 |
| 10385480375556 | K061830 | 000 |
| 10385480375624 | K061830 | 000 |
| 00385480412247 | K061830 | 000 |
| 00385480407298 | K061830 | 000 |
| 00385480407236 | K061830 | 000 |
| 00385480407229 | K061830 | 000 |
| 00385480407212 | K061830 | 000 |
| 00385480400947 | K061830 | 000 |
| 00385480387323 | K061830 | 000 |
| 00385480382977 | K061830 | 000 |
| 00385480382816 | K061830 | 000 |
| 00385480381857 | K061830 | 000 |
| 00385480380430 | K061830 | 000 |
| 10385480380253 | K061830 | 000 |
| 00385480379380 | K061830 | 000 |
| 00385480351508 | K061830 | 000 |