Company ยท US
Medical & Scientific Designs, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1986. 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 |
|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | 3 |
| CDD | Radioassay, Vitamin B12 | 1 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DON | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| LCA | Radioimmunoassay, Theophylline | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 1986 | K862960 | PHASE II FERRITIN RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. | DBF |
| Oct 3, 1985 | K853224 | PHASE II B-12/FOLATE KIT Medical & Scientific Designs, Inc. | CDD |
| Apr 25, 1984 | K840901 | PHASE II FREE T4 KIT Medical & Scientific Designs, Inc. | CEC |
| Apr 19, 1984 | K840328 | PHASE II HCG KIT Medical & Scientific Designs, Inc. | JHI |
| Feb 4, 1984 | K834219 | PHASE II CORTISOL KIT Medical & Scientific Designs, Inc. | CGR |
| Jan 24, 1984 | K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY Medical & Scientific Designs, Inc. | LCA |
| Sep 12, 1983 | K832499 | PHASE II TSH KIT Medical & Scientific Designs, Inc. | JLW |
| Aug 24, 1983 | K832210 | GAMMA PHOTON GAMMA COUNTER Medical & Scientific Designs, Inc. | JJJ |
| Aug 24, 1983 | K832209 | KINETI COUNT 24 GAMMA COUNTER Medical & Scientific Designs, Inc. | JJJ |
| May 9, 1983 | K831064 | PHASE II T3 RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. | CDP |
| Apr 18, 1983 | K830900 | UPTAKE T3 RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. | KHQ |
| Apr 5, 1983 | K830642 | PHASE THYROXINE RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. | CDX |
| Apr 5, 1983 | K830533 | PHASE II DIGOXIN RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. | DON |
| Mar 10, 1983 | K830365 | KINETI COUNT 48 IMMUNOASSAY SYSTEM Medical & Scientific Designs, Inc. | JJJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||