Company ยท US
Serono Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1984. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHP | Radioimmunoassay, Estradiol | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 |
| CJM | Radioimmunoassay, Aldosterone | 1 |
| DHI | Ng3m(Bo), Antigen, Antiserum, Control | 1 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| JME | Radioimmunoassay, Glucagon | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 2, 1984 | K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT Serono Laboratories, Inc. | CJM |
| Mar 31, 1981 | K810695 | ESTRIOL RADIOIMMUNOASSAY TEST KIT Serono Laboratories, Inc. | CHP |
| Mar 27, 1981 | K810625 | HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- Serono Laboratories, Inc. | DHI |
| Oct 30, 1979 | K792043 | PAP-CHECK RIA KIT Serono Laboratories, Inc. | JFH |
| May 23, 1979 | K790679 | ESTRADIOL RIA KIT Serono Laboratories, Inc. | CHP |
| May 3, 1979 | K790440 | PROGESTERONE Serono Laboratories, Inc. | JLS |
| Feb 22, 1979 | K782143 | RIA KIT, GLUCOSE Serono Laboratories, Inc. | JME |
| Jan 17, 1979 | K782103 | RIA KIT, NEONATAL T4 Serono Laboratories, Inc. | CDX |
| Dec 20, 1978 | K781733 | RIA KIT, PREG-STAT Serono Laboratories, Inc. | JHI |
| Aug 14, 1978 | K781285 | INSULIN RIA KIT Serono Laboratories, Inc. | CFP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||