The following data is part of a premarket notification filed by Medical Diagnostics, Ca. with the FDA for Medica Iif-anti-thyroid Antibody Test.
| Device ID | K843343 |
| 510k Number | K843343 |
| Device Name: | MEDICA IIF-ANTI-THYROID ANTIBODY TEST |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | MEDICAL DIAGNOSTICS, CA. 2382 CAMINO VIDA ROBLE SUITE I Calsbad , CA 92008 - |
| Contact | Paul Bartl |
| Correspondent | Paul Bartl MEDICAL DIAGNOSTICS, CA. 2382 CAMINO VIDA ROBLE SUITE I Calsbad , CA 92008 - |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-27 |
| Decision Date | 1984-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545027179 | K843343 | 000 |
| 00813545027162 | K843343 | 000 |
| 00813545027155 | K843343 | 000 |
| 00813545027148 | K843343 | 000 |
| 00813545026752 | K843343 | 000 |
| 00813545026745 | K843343 | 000 |
| 00813545026738 | K843343 | 000 |
| 00813545026721 | K843343 | 000 |