Company ยท US
Micromedic Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1993. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 8 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 6 |
| CDX | Radioimmunoassay, Total Thyroxine | 4 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 4 |
| CDD | Radioassay, Vitamin B12 | 2 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 2 |
| CGI | Radioimmunoassay, Estriol | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 |
| KHQ | Radioassay, Triiodothyronine Uptake | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| CGN | Acid, Folic, Radioimmunoassay | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JTC | Device, Microtiter Diluting/Dispensing | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 1993 | K923643 | MEDICOOL Micromedic Systems | ILO |
| Jul 31, 1987 | K872309 | MICROMEDIC COMBOSTAT LH/FSH KIT Micromedic Systems | CGJ |
| May 26, 1987 | K871505 | AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT Micromedic Systems | JLW |
| May 26, 1987 | K871008 | MICROMEDIC NEONATAL T4 KIT Micromedic Systems | CDX |
| May 26, 1987 | K870904 | MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT Micromedic Systems | JLW |
| Apr 1, 1987 | K870245 | AUTOPAK TSH MONOCLONAL IRMA KIT Micromedic Systems | JLW |
| Aug 4, 1986 | K862206 | TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER Micromedic Systems | JJJ |
| Jul 14, 1986 | K860813 | MICROMEDIC HTSH MONOCLONAL IRMA KIT Micromedic Systems | JLW |
| May 23, 1986 | K861262 | MMS T3 UPTAKE Micromedic Systems | KHQ |
| Apr 24, 1986 | K861320 | MMS T4 RIA KIT Micromedic Systems | CDX |
| Sep 16, 1985 | K853127 | MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL) Micromedic Systems | CDD |
| Aug 9, 1984 | K842902 | MICROSTAT GAMMA COUNTER Micromedic Systems | JJJ |
| Apr 19, 1984 | K840938 | HIGH SPEED DISPENSER Micromedic Systems | JQW |
| Mar 23, 1984 | K840188 | MICROMEDIC LH & FSH RIA KIT Micromedic Systems | CEP |
| Mar 19, 1984 | K834590 | ACCUFLEX Micromedic Systems | JQW |
| Sep 12, 1983 | K832462 | AUTOPAK NEONATAL TSH RIA KIT Micromedic Systems | JLW |
| Jun 8, 1983 | K831264 | BHCG RIA KIT Micromedic Systems | JHI |
| Mar 10, 1983 | K830157 | DIGIFLEX AUTOMATIC PIPETTE Micromedic Systems | JQW |
| Dec 3, 1982 | K823275 | AUTOPAK FERRITIN TEST DELIVERY SYS Micromedic Systems | DBF |
| Oct 26, 1982 | K822578 | MICROMEDIC ESTRIOL RIA KIT Micromedic Systems | CGI |
| Jun 24, 1982 | K821678 | AUTOPAK ESTRIOL TEST DELIVERY SYSTEM Micromedic Systems | CGI |
| Mar 16, 1982 | K820376 | MICROMEDIC SYSTEMS ISOFLEX Micromedic Systems | JJJ |
| Jan 22, 1982 | K813645 | MICROMEDIC HTSH RIA KIT Micromedic Systems | JLW |
| Dec 31, 1981 | K813525 | IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY Micromedic Systems | JLW |
| Jul 10, 1981 | K811808 | AUTOPAK-12 FERRITIN KIT Micromedic Systems | DBF |
| Feb 4, 1981 | K810186 | MICROMEDIC SYSTEMS' AUTOPAK Micromedic Systems | CGN |
| Jan 12, 1981 | K803252 | MICROMEDIC REAGENT DISPENSER Micromedic Systems | JTC |
| Apr 16, 1980 | K800606 | MICROMEDIC AUTOMATIC DILUTER Micromedic Systems | JQW |
| Feb 13, 1980 | K800075 | MICROMEDIC PUNCH & ELUTER Micromedic Systems | JQW |
| Jan 17, 1980 | K792662 | AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM Micromedic Systems | KHQ |
| Dec 6, 1979 | K792279 | AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM Micromedic Systems | CFP |
| Oct 11, 1979 | K791375 | AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM Micromedic Systems | CDP |
| Sep 27, 1979 | K790347 | AUTO PAK VITAMIN B-12 Micromedic Systems | CDD |
| Aug 28, 1979 | K791324 | MICROMEDIC APS2 Micromedic Systems | JQW |
| Aug 16, 1979 | K791325 | AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM Micromedic Systems | DPO |
| Jun 27, 1979 | K790907 | AUTOPAK TEST DELIVERY SYSTEM Micromedic Systems | CDX |
| Jun 27, 1979 | K790906 | AUTOPAK CORTISOL TEST DELIVERY SYSTEM Micromedic Systems | CGR |
| May 15, 1979 | K790665 | NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM Micromedic Systems | CDX |
| Mar 21, 1979 | K790260 | NTSH AUTOPAK TEST DELIVERY SYSTEM Micromedic Systems | JLW |
| Aug 14, 1978 | K781086 | INSULIN AUTOPAK Micromedic Systems | CFP |
| Mar 22, 1978 | K780383 | COUNTER, RADIOASSAY, AUTO., MICROMEDIC Micromedic Systems | JJJ |
| Jul 20, 1976 | K760006 | RADIOASSAY, CONCEPT 4 Micromedic Systems |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||