510(k) K033079
- Device
- CHLAMYDIA IGG ELISA TEST SYSTEM
- Applicant
- TRINITY BIOTECH USA
- 510(k) number
- K033079
- Product code
- LJC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-26
- Date received
- 2003-09-29
- Regulation
- 866.3120
- Classification name
- Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bonnie B DeJoy
- Address
- P.O. Box 1059 Jamestown NY US 14702 14702
FDA Registration Numbers#
- 3022178699
- 3033507883
- 2029372
- 3012494290
- 3005360469
- 3002792284
- 3043226252
- 1318354
- 8030124
- 3003750284
Source Documents#
Other 510(k) Records For Product Code LJC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K032330 | CT OIA | Thermo Biostar, Inc. | 2004-03-02 |
| K033865 | IDEIA PCE CHLAMYDIA | Dakocytomation, Ltd. | 2004-01-21 |
| K982210 | MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA | Dade Behring, Inc. | 1998-07-09 |
| K962558 | CHLAMYDIA IGG ELISA TEST SYSTEM | Armkel, LLC | 1997-02-24 |
| K960850 | ACCESS CHLAMYDIA ASSAY | Bio-Rad Laboratories, Inc. | 1997-02-04 |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Biomerieux Vitek, Inc. | 1996-10-07 |
| K936054 | IMX SELECT CHLAMYDIA | Abbott Laboratories | 1996-05-30 |
| K940564 | IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION | Dako Diagnostics , Ltd. | 1996-01-11 |
| K951010 | CHLAMYDIA OIA | Biostar, Inc. | 1995-10-07 |
| K946276 | QUICKVUE(R) CHLAMYDIA TEST | Quidel Corp. | 1995-05-19 |
| K935807 | ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY | Bio-Rad Laboratories, Inc. | 1995-05-19 |
| K935393 | CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY | Bio-Rad Laboratories, Inc. | 1994-09-20 |
| K926090 | SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT | Syva Co. | 1993-09-30 |
| K921747 | MICRO TRAK XL SYSTEM | Syva Co. | 1992-10-01 |
| K921462 | MICROTRAK(R) II CHLAMYDIA EIA ASSAY | Syva Co. | 1992-09-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary