The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunowell Tpo (microsome) Test.
| Device ID | K905486 |
| 510k Number | K905486 |
| Device Name: | IMMUNOWELL TPO (MICROSOME) TEST |
| Classification | Immunochemical, Thyroglobulin Autoantibody |
| Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Contact | Bryan L Kiehl |
| Correspondent | Bryan L Kiehl GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Product Code | JNL |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-06 |
| Decision Date | 1991-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613745030203 | K905486 | 000 |