The following data is part of a premarket notification filed by Columbia Bioscience, Inc. with the FDA for Is Anti-tpo Igg Elisa Test System.
| Device ID | K984228 |
| 510k Number | K984228 |
| Device Name: | IS ANTI-TPO IGG ELISA TEST SYSTEM |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | COLUMBIA BIOSCIENCE, INC. 8775 M CENTRE PARK DR. #559 Columbia, MD 21045 |
| Contact | Norman Jenkins |
| Correspondent | Norman Jenkins COLUMBIA BIOSCIENCE, INC. 8775 M CENTRE PARK DR. #559 Columbia, MD 21045 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-25 |
| Decision Date | 1999-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817273020273 | K984228 | 000 |
| B3507204500 | K984228 | 000 |