Company ยท US
Helix Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2000. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 6 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 3 |
| LKJ | Antinuclear Antibody, Antigen, Control | 2 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2000 | K001900 | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST Helix Diagnostics, Inc. | LRM |
| Apr 5, 2000 | K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST Helix Diagnostics, Inc. | LLL |
| May 12, 1998 | K980337 | DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM Helix Diagnostics, Inc. | LJM |
| Mar 20, 1996 | K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT Helix Diagnostics, Inc. | LRM |
| Dec 15, 1995 | K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT Helix Diagnostics, Inc. | LKJ |
| Dec 15, 1995 | K954700 | ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT Helix Diagnostics, Inc. | LKJ |
| Aug 24, 1995 | K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT Helix Diagnostics, Inc. | LLL |
| Jul 18, 1995 | K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT Helix Diagnostics, Inc. | LJM |
| Jul 17, 1995 | K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT Helix Diagnostics, Inc. | LJM |
| Apr 20, 1994 | K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT Helix Diagnostics, Inc. | LKO |
| Apr 20, 1994 | K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT Helix Diagnostics, Inc. | LKP |
| Sep 24, 1993 | K932850 | ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN Helix Diagnostics, Inc. | LLL |
| Aug 5, 1993 | K932419 | ANTI-SS-B/LA ANTIBODY TEST Helix Diagnostics, Inc. | LLL |
| Jul 16, 1993 | K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT Helix Diagnostics, Inc. | LLL |
| Nov 5, 1991 | K913041 | ANTI-DSDNA ANTIBODY TEST Helix Diagnostics, Inc. | LLL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||