The following data is part of a premarket notification filed by Tokyo Boeki Medical System Ltd. with the FDA for Prestige Models 24i And 400 And Mgc Model 240.
| Device ID | K040958 |
| 510k Number | K040958 |
| Device Name: | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | TOKYO BOEKI MEDICAL SYSTEM LTD. 5304 GOLDEN MOSS TRAIL Raleigh, NC 27613 -5662 |
| Contact | James M Clinton |
| Correspondent | James M Clinton TOKYO BOEKI MEDICAL SYSTEM LTD. 5304 GOLDEN MOSS TRAIL Raleigh, NC 27613 -5662 |
| Product Code | JJE |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-13 |
| Decision Date | 2005-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04580262040014 | K040958 | 000 |
| 04580262010284 | K040958 | 000 |
| 04580262010277 | K040958 | 000 |
| 04580262010260 | K040958 | 000 |
| 04580262010222 | K040958 | 000 |
| 04580262010208 | K040958 | 000 |
| 04580262049826 | K040958 | 000 |
| 04580262049819 | K040958 | 000 |
| 04580262049802 | K040958 | 000 |
| 04580262040076 | K040958 | 000 |
| 04580262010321 | K040958 | 000 |
| 04580262010291 | K040958 | 000 |
| 04580262010307 | K040958 | 000 |
| 04580262010338 | K040958 | 000 |
| 04580262020016 | K040958 | 000 |
| 04580262016002 | K040958 | 000 |
| 04580262046825 | K040958 | 000 |
| 04580262046818 | K040958 | 000 |
| 04580262046528 | K040958 | 000 |
| 04580262046511 | K040958 | 000 |
| 04580262028227 | K040958 | 000 |
| 04580262016019 | K040958 | 000 |
| 04580262010352 | K040958 | 000 |
| 04580262010345 | K040958 | 000 |
| 04580262010314 | K040958 | 000 |