The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Rfa-300 Rapid Flow Analyzer W/computer.
| Device ID | K883020 |
| 510k Number | K883020 |
| Device Name: | RFA-300 RAPID FLOW ANALYZER W/COMPUTER |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Contact | Raymond L Pavitt |
| Correspondent | Raymond L Pavitt ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-19 |
| Decision Date | 1988-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000502 | K883020 | 000 |
| 00725609000496 | K883020 | 000 |