The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Orgentec Anti-tpo Elisa.
Device ID | K952129 |
510k Number | K952129 |
Device Name: | ORGENTEC ANTI-TPO ELISA |
Classification | System, Test, Thyroid Autoantibody |
Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. 7 COLCHESTER RD. Windham, NH 03087 |
Contact | Richard E Conley |
Correspondent | Richard E Conley AMERICAN LABORATORY PRODUCTS CO., LTD. 7 COLCHESTER RD. Windham, NH 03087 |
Product Code | JZO |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-08 |
Decision Date | 1995-06-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260157080027 | K952129 | 000 |
00404847435610 | K952129 | 000 |
04048474035612 | K952129 | 000 |
00840239035615 | K952129 | 000 |