Company ยท US
Simmler & Son, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1978. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 4 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 27, 1978 | K780817 | GLOBIN-TERGE Simmler & Son, Inc. | |
| Dec 6, 1977 | K771906 | PHOSPHATE Simmler & Son, Inc. | CDT |
| Dec 6, 1977 | K771905 | GLYCEROL SUBSTRATE Simmler & Son, Inc. | CDT |
| Dec 6, 1977 | K771904 | GLYCEROL KINASE Simmler & Son, Inc. | CDT |
| Dec 6, 1977 | K771903 | LIPASE Simmler & Son, Inc. | CDT |
| Jan 12, 1977 | K761086 | REAGENTS Simmler & Son, Inc. | JJC |
| Nov 1, 1976 | K760476 | REAGENT, LACTATE DEHYDROGENASE Simmler & Son, Inc. | CFJ |
| Oct 29, 1976 | K760480 | REAGENT, TOTAL PROTEIN DETERMINATION Simmler & Son, Inc. | CEK |
| Oct 29, 1976 | K760479 | REAGENT, TOTAL BILIRUBIN DETERMINATION Simmler & Son, Inc. | CIG |
| Oct 29, 1976 | K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. Simmler & Son, Inc. | CDW |
| Oct 29, 1976 | K760477 | REAGENTS-4 FOR URIC ACID DETERMINATION Simmler & Son, Inc. | CDH |
| Oct 29, 1976 | K760475 | REAGENT, CALCIUM DETERMINATION Simmler & Son, Inc. | CIC |
| Oct 29, 1976 | K760474 | REAGENT, ALKALINE PHOSPHATASE DETERM. Simmler & Son, Inc. | CJE |
| Oct 29, 1976 | K760473 | REAGENT, ALBUMIN DETERMINATION Simmler & Son, Inc. | CIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||