The following data is part of a premarket notification filed by Breit Laboratories, Inc. with the FDA for Igm Rheumatoid Factor Test Kit.
| Device ID | K851099 |
| 510k Number | K851099 |
| Device Name: | IGM RHEUMATOID FACTOR TEST KIT |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | BREIT LABORATORIES, INC. 2510 BOATMAN AVE. West Sacramento, CA 95691 |
| Contact | Leroy L Kondo |
| Correspondent | Leroy L Kondo BREIT LABORATORIES, INC. 2510 BOATMAN AVE. West Sacramento, CA 95691 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-19 |
| Decision Date | 1985-04-25 |