Company ยท US
Simplicity Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1997. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 1997 | K970100 | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL Simplicity Diagnostics, Inc. | MJX |
| Oct 5, 1992 | K922726 | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL Simplicity Diagnostics, Inc. | KTN |
| Oct 5, 1992 | K922725 | TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL Simplicity Diagnostics, Inc. | DHR |
| Oct 5, 1992 | K922722 | TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL Simplicity Diagnostics, Inc. | DCK |
| Sep 18, 1992 | K922723 | TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL Simplicity Diagnostics, Inc. | GTQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||