The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Sera-tek Thyroglobulin Antibody Test.
Device ID | K865020 |
510k Number | K865020 |
Device Name: | SERA-TEK THYROGLOBULIN ANTIBODY TEST |
Classification | Thyroglobulin, Antigen, Antiserum, Control |
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 | DDC |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-23 |
Decision Date | 1987-02-02 |