The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for El-rf/3 (igm-igg-iga) Kit.
| Device ID | K941398 |
| 510k Number | K941398 |
| Device Name: | EL-RF/3 (IGM-IGG-IGA) KIT |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Contact | Christopher J Froelich,md |
| Correspondent | Christopher J Froelich,md THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-22 |
| Decision Date | 1995-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854473003033 | K941398 | 000 |