The following data is part of a premarket notification filed by Thermogenesis Corp. with the FDA for Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (primary).
| Device ID | K081345 |
| 510k Number | K081345 |
| Device Name: | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | THERMOGENESIS CORP. 2711 CITRUS RD. Rancho Cordova, CA 95742 |
| Contact | John Chapman, Phd |
| Correspondent | John Chapman, Phd THERMOGENESIS CORP. 2711 CITRUS RD. Rancho Cordova, CA 95742 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-14 |
| Decision Date | 2008-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886368000551 | K081345 | 000 |