The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Rheumatoid Factor (rf) Reagenti A Latex Slide Test.
| Device ID | K962015 |
| 510k Number | K962015 |
| Device Name: | RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Contact | K.c. Chen, Ph.d. |
| Correspondent | K.c. Chen, Ph.d. TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-22 |
| Decision Date | 1996-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486002423 | K962015 | 000 |