The following data is part of a premarket notification filed by Microscan Div. Baxter Healthcare Corp. with the FDA for Rabbit Kidney Culture Cells (first Pass).
| Device ID | K871033 |
| 510k Number | K871033 |
| Device Name: | RABBIT KIDNEY CULTURE CELLS (FIRST PASS) |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento, CA 95691 |
| Contact | Lorraine Weaver |
| Correspondent | Lorraine Weaver MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento, CA 95691 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-16 |
| Decision Date | 1987-03-31 |