The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Blood Gas/ise Linearity Control.
| Device ID | K920285 |
| 510k Number | K920285 |
| Device Name: | BLOOD GAS/ISE LINEARITY CONTROL |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Contact | Ram Nunna |
| Correspondent | Ram Nunna PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-22 |
| Decision Date | 1992-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852676007216 | K920285 | 000 |
| 00852676007124 | K920285 | 000 |
| 00852676007131 | K920285 | 000 |
| 00852676007148 | K920285 | 000 |
| 00852676007155 | K920285 | 000 |
| 00852676007162 | K920285 | 000 |
| 00852676007179 | K920285 | 000 |
| 00852676007186 | K920285 | 000 |
| 00852676007193 | K920285 | 000 |
| 00852676007209 | K920285 | 000 |
| 10852676007114 | K920285 | 000 |