The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Orgentec Anti-pr3 (c-anca) Elisa.
Device ID | K974702 |
510k Number | K974702 |
Device Name: | ORGENTEC ANTI-PR3 (C-ANCA) ELISA |
Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
Contact | Richard Conley |
Correspondent | Richard Conley AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
Product Code | MOB |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-08 |
Decision Date | 1998-02-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260157080171 | K974702 | 000 |
00404847435962 | K974702 | 000 |
04048474035964 | K974702 | 000 |
00840239035967 | K974702 | 000 |