The following data is part of a premarket notification filed by Primus Corp. with the FDA for Primus Variant System Pvs99.
| Device ID | K955283 |
| 510k Number | K955283 |
| Device Name: | PRIMUS VARIANT SYSTEM PVS99 |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | PRIMUS CORP. P.O. BOX 22599 Kansas City, MO 64113 |
| Contact | Jim Noffsinger |
| Correspondent | Jim Noffsinger PRIMUS CORP. P.O. BOX 22599 Kansas City, MO 64113 |
| Product Code | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-16 |
| Decision Date | 1996-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516748193 | K955283 | 000 |
| 05391516744119 | K955283 | 000 |
| 05391516744195 | K955283 | 000 |
| 05391516744201 | K955283 | 000 |
| 05391516744232 | K955283 | 000 |
| 05391516744249 | K955283 | 000 |
| 05391516744256 | K955283 | 000 |
| 05391516744263 | K955283 | 000 |
| 05391516744522 | K955283 | 000 |
| 05391516744539 | K955283 | 000 |
| 05391516748179 | K955283 | 000 |
| 05391516748186 | K955283 | 000 |
| 05391516744102 | K955283 | 000 |