The following data is part of a premarket notification filed by American Laboratory Products Co., Ltd. with the FDA for Cic-c1q Eia.
| Device ID | K012576 |
| 510k Number | K012576 |
| Device Name: | CIC-C1Q EIA |
| Classification | Complement C1q, Antigen, Antiserum, Control |
| Applicant | AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Contact | Richard E Conley |
| Correspondent | Richard E Conley AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 Windham, NH 03087 |
| Product Code | DAK |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-09 |
| Decision Date | 2002-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBUHEKCIC1 | K012576 | 000 |