The following data is part of a premarket notification filed by Columbia Bioscience, Inc. with the FDA for Anti-tg Igg Elisa Test System.
| Device ID | K983553 |
| 510k Number | K983553 |
| Device Name: | ANTI-TG 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 | 1998-10-09 |
| Decision Date | 1998-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817273020280 | K983553 | 000 |
| B3507204600 | K983553 | 000 |