Company ยท US
Diatech, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1988. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 3 |
| KQJ | System, Fibrinogen Determination | 2 |
| GGN | Plasma, Coagulation Control | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 |
| GIR | Reagent, Russel Viper Venom | 1 |
| GIS | Test, Fibrinogen | 1 |
| GJS | Test, Time, Prothrombin | 1 |
| JPK | Mixture, Hematology Quality Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 9, 1988 | K881685 | FIBRINOGENTEST-O Diatech, Inc. | GIS |
| Mar 12, 1986 | K854938 | COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. Diatech, Inc. | JPA |
| Jan 6, 1986 | K854090 | DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT Diatech, Inc. | JPA |
| Jan 6, 1986 | K854089 | DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT Diatech, Inc. | JPA |
| Sep 11, 1984 | K842286 | DIA T1, T2 & T3 Diatech, Inc. | JPK |
| Jun 1, 1984 | K841523 | OWREN'S VERONAL BUFFERR Diatech, Inc. | JPA |
| Jun 1, 1984 | K841462 | HEPARIN COAGULATION CONTROL PLASMA 1- Diatech, Inc. | JPA |
| Jun 1, 1984 | K841366 | DIA FIBRIN Diatech, Inc. | KQJ |
| Jun 1, 1984 | K841365 | DIA REPTIN Diatech, Inc. | GIR |
| May 2, 1984 | K841461 | COAGULATION CONTROL PLASMA LEVEL 1/2/3 Diatech, Inc. | GGP |
| May 1, 1984 | K840802 | DIA THROMBIN DIA PLASTIN Diatech, Inc. | GJS |
| Apr 30, 1984 | K841522 | CALCIUM CHLORIDE Diatech, Inc. | GGW |
| Apr 30, 1984 | K840928 | FACTOR DEFICIENT SUBSTRATE PLASMA VIII Diatech, Inc. | GGP |
| Apr 30, 1984 | K840927 | FACTOR DEFICIENT SUBSTRATE PLASMA II Diatech, Inc. | GGP |
| Apr 25, 1984 | K840801 | DIA-H 1/2/3 & DIA-HT 1/2/3 Diatech, Inc. | |
| Apr 23, 1984 | K840288 | DIACELIN Diatech, Inc. | GGN |
| Feb 4, 1984 | K834571 | FIBRINOGEN TEST Diatech, Inc. | KQJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||