Medical & Scientific Designs, Inc.
Mchenry, IL, US
Medical & Scientific Designs, Inc. appears in FDA device records in Mchenry, IL. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Medical & Scientific Designs, Inc. between 1983 and 1986. The busiest year on record is 1983, with 8. The most recent is 1986, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 8 |
| 1984 | 4 |
| 1985 | 1 |
| 1986 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K862960 | PHASE II FERRITIN RADIOIMMUNOASSAY KIT | DBF | Substantially Equivalent | |
| K853224 | PHASE II B-12/FOLATE KIT | CDD | Substantially Equivalent | |
| K840901 | PHASE II FREE T4 KIT | CEC | Substantially Equivalent | |
| K840328 | PHASE II HCG KIT | JHI | Substantially Equivalent | |
| K834219 | PHASE II CORTISOL KIT | CGR | Substantially Equivalent | |
| K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | LCA | Substantially Equivalent | |
| K832499 | PHASE II TSH KIT | JLW | Substantially Equivalent | |
| K832210 | GAMMA PHOTON GAMMA COUNTER | JJJ | Substantially Equivalent | |
| K832209 | KINETI COUNT 24 GAMMA COUNTER | JJJ | Substantially Equivalent | |
| K831064 | PHASE II T3 RADIOIMMUNOASSAY KIT | CDP | Substantially Equivalent | |
| K830900 | UPTAKE T3 RADIOIMMUNOASSAY KIT | KHQ | Substantially Equivalent | |
| K830642 | PHASE THYROXINE RADIOIMMUNOASSAY KIT | CDX | Substantially Equivalent | |
| K830533 | PHASE II DIGOXIN RADIOIMMUNOASSAY KIT | DON | Substantially Equivalent | |
| K830365 | KINETI COUNT 48 IMMUNOASSAY SYSTEM | JJJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJJCounter (Beta, Gamma) For Clinical Use
- DBFFerritin, Antigen, Antiserum, Control
- KHQRadioassay, Triiodothyronine Uptake
- CDDRadioassay, Vitamin B12
- CGRRadioimmunoassay, Cortisol
- DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- CECRadioimmunoassay, Free Thyroxine
- LCARadioimmunoassay, Theophylline
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain