The following data is part of a premarket notification filed by Clark Laboratories, Inc. with the FDA for Rubella Igm.
| Device ID | K921573 |
| 510k Number | K921573 |
| Device Name: | RUBELLA IGM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | CLARK LABORATORIES, INC. 53 CEDAR LAKE RD. Blairstown, NJ 07825 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus CLARK LABORATORIES, INC. 53 CEDAR LAKE RD. Blairstown, NJ 07825 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-02 |
| Decision Date | 1992-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747011 | K921573 | 000 |
| 05391516743457 | K921573 | 000 |
| 05391516743440 | K921573 | 000 |