The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Hemoccult Ict.
| Device ID | K080812 |
| 510k Number | K080812 |
| Device Name: | HEMOCCULT ICT |
| Classification | Reagent, Occult Blood |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 PO BOX 8000 Brea, CA 92822 |
| Contact | Sylvia Zorich |
| Correspondent | Sylvia Zorich BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 PO BOX 8000 Brea, CA 92822 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-24 |
| Decision Date | 2008-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590390341 | K080812 | 000 |
| 15099590227302 | K080812 | 000 |
| 15099590221669 | K080812 | 000 |
| 15099590221461 | K080812 | 000 |
| 15099590221157 | K080812 | 000 |
| 15099590180072 | K080812 | 000 |