The following data is part of a premarket notification filed by Abbott Point Of Care Inc. with the FDA for I-stat Total Beta-hcg Test, I-stat Total Beta-hcg Controls, I-stat Total Beta-hcg Calibration Verification Materials.
| Device ID | K133002 |
| 510k Number | K133002 |
| Device Name: | I-STAT Total Beta-hCG Test, I-STAT Total Beta-hCG Controls, I-STAT Total Beta-hCG Calibration Verification Materials |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | ABBOTT POINT OF CARE INC. 400 COLLEGE ROAD EAST Princeton, NJ 08540 |
| Contact | Melissa Robinson |
| Correspondent | Melissa Robinson ABBOTT POINT OF CARE INC. 400 COLLEGE ROAD EAST Princeton, NJ 08540 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-24 |
| Decision Date | 2015-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749001009 | K133002 | 000 |