The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Cab Total Iron Procedure, Liquicolor.
| Device ID | K880467 |
| 510k Number | K880467 |
| Device Name: | STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | William Campbell,phd |
| Correspondent | William Campbell,phd STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-03 |
| Decision Date | 1988-03-24 |