The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Is-anti-sm Test System.
| Device ID | K970220 |
| 510k Number | K970220 |
| Device Name: | IS-ANTI-SM TEST SYSTEM |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Lynne Stirling, Ph.d. |
| Correspondent | Lynne Stirling, Ph.d. DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817273020075 | K970220 | 000 |
| 00817273020051 | K970220 | 000 |
| B3507202400 | K970220 | 000 |