The following data is part of a premarket notification filed by Technia Diagnostics Ltd. with the FDA for Autofluor V.
| Device ID | K861978 |
| 510k Number | K861978 |
| Device Name: | AUTOFLUOR V |
| Classification | Anti-dna Indirect Immunofluorescent Solid Phase |
| Applicant | TECHNIA DIAGNOSTICS LTD. 15TH & OAK P.O. BOX 338 ELWOOD, KS 66024 |
| Contact | JAMES A BAYLISS |
| Correspondent | JAMES A BAYLISS TECHNIA DIAGNOSTICS LTD. 15TH & OAK P.O. BOX 338 ELWOOD, KS 66024 |
| Product Code | KTL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-21 |
| Decision Date | 1986-06-10 |