The following data is part of a premarket notification filed by Immunoprobe, Inc. with the FDA for Microsomal Eia Test Kit.
| Device ID | K941361 |
| 510k Number | K941361 |
| Device Name: | MICROSOMAL EIA TEST KIT |
| Classification | Immunochemical, Thyroglobulin Autoantibody |
| Applicant | IMMUNOPROBE, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Patricia B Shrader |
| Correspondent | Patricia B Shrader IMMUNOPROBE, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | JNL |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-21 |
| Decision Date | 1994-05-11 |