Company ยท GB
Shield Diagnostics, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2000. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 3 |
| MID | System, Test, Anticardiolipin Immunological | 3 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 |
| LKJ | Antinuclear Antibody, Antigen, Control | 2 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 2 |
| LKP | Anti-Sm Antibody, Antigen And Control | 2 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| JNB | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | 1 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 |
| LYR | Helicobacter Pylori | 1 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2000 | K000398 | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 Shield Diagnostics, Ltd., GB | GGP |
| Oct 15, 1998 | K982879 | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY Shield Diagnostics, Ltd., GB | MSV |
| Aug 21, 1998 | K980885 | SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY Shield Diagnostics, Ltd., GB | GGP |
| Mar 17, 1998 | K972981 | SHIELD HELICO-G2 ELISA KIT Shield Diagnostics, Ltd., GB | LYR |
| Nov 15, 1996 | K962825 | SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY Shield Diagnostics, Ltd., GB | GGP |
| Nov 7, 1996 | K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT Shield Diagnostics, Ltd., GB | DBL |
| Jun 12, 1996 | K961515 | QUANTASE PHENYLALANINE ASSAY Shield Diagnostics, Ltd., GB | JNB |
| May 30, 1996 | K955303 | DIASTAT ANTI-CARDIOLIPIN KIT Shield Diagnostics, Ltd., GB | MID |
| Jun 30, 1995 | K952183 | DIASTAT ANTI-THYROGLOBULIN KIT Shield Diagnostics, Ltd., GB | JZO |
| Jun 30, 1995 | K951487 | DIASTAT ANTI-THYROID PEROXIDASE KIT Shield Diagnostics, Ltd., GB | JZO |
| Mar 6, 1995 | K943630 | DIASTAT ANTI-MPO (PANCA) KIT Shield Diagnostics, Ltd., GB | MOB |
| Mar 6, 1995 | K942813 | DIASTAT ANTI-PR3 (C-ANCA) KIT Shield Diagnostics, Ltd., GB | MOB |
| Nov 21, 1994 | K944505 | DIASTAT ENA SINGLE WELL SCREEN KIT Shield Diagnostics, Ltd., GB | LLL |
| Nov 15, 1993 | K932876 | DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT Shield Diagnostics, Ltd., GB | LKJ |
| Oct 15, 1993 | K932877 | DIASTAT ANTI-CENTROMERE KIT Shield Diagnostics, Ltd., GB | LLL |
| Sep 25, 1992 | K923886 | DIASTAT TOTAL ANTI-CARDIOLIPIN KIT Shield Diagnostics, Ltd., GB | MID |
| Aug 3, 1992 | K921265 | DIASTAT ANTI-CARDIOLIPIN KIT Shield Diagnostics, Ltd., GB | MID |
| Jul 14, 1992 | K920616 | DIASTAT ANTI-HISTONE KIT Shield Diagnostics, Ltd., GB | LJM |
| Jun 19, 1992 | K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT Shield Diagnostics, Ltd., GB | DBM |
| Jul 30, 1991 | K912292 | DIASTAT ANTI-JO-1 KIT Shield Diagnostics, Ltd., GB | DHN |
| Jul 30, 1991 | K912291 | DISTAT ANTI-SCL-70 KIT Shield Diagnostics, Ltd., GB | LKJ |
| Dec 13, 1990 | K905386 | DISTAT ANTI-DSDNA KIT Shield Diagnostics, Ltd., GB | KTL |
| Dec 13, 1990 | K905194 | DIASTAT ANTI-RO (SS-A) Shield Diagnostics, Ltd., KN | LKO |
| Dec 13, 1990 | K905193 | DIASTAT ANTI-LA (SS-B) Shield Diagnostics, Ltd., KN | LKO |
| Dec 7, 1990 | K905192 | DIASTAT ANTI-SM/RNP Shield Diagnostics, Ltd., KN | LKP |
| Dec 7, 1990 | K905191 | DIASTAT ANTI-SM Shield Diagnostics, Ltd., KN | LKP |
| Dec 7, 1990 | K905190 | DIASTAT ENA PROFILE Shield Diagnostics, Ltd., KN | LJM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||