The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for Theratest Kit (modification).
| Device ID | K955481 |
| 510k Number | K955481 |
| Device Name: | THERATEST KIT (MODIFICATION) |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Contact | Christopher J Froelich |
| Correspondent | Christopher J Froelich THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-15 |
| Decision Date | 1996-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854473003163 | K955481 | 000 |