The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Sera-tek Microsomal Antibody Test.
| Device ID | K865053 |
| 510k Number | K865053 |
| Device Name: | SERA-TEK MICROSOMAL ANTIBODY TEST |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Contact | John H Engelmann |
| Correspondent | John H Engelmann MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-24 |
| Decision Date | 1987-02-18 |