ABBOTT TESTPACK CHLAMYDIA
FDA 510(k) clearance K893676 · decided 1989-07-25
Clearance details
- K-number
- K893676
- Device name
- ABBOTT TESTPACK CHLAMYDIA
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1989-05-16
- Decision date
- 1989-07-25
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- LJC
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CT OIA (K032330) | Thermo Biostar, Inc. | 2004-03-02 |
| IDEIA PCE CHLAMYDIA (K033865) | Dakocytomation, Ltd. | 2004-01-21 |
| CHLAMYDIA IGG ELISA TEST SYSTEM (K033079) | Trinity Biotech USA | 2003-11-26 |
| MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (K982210) | Dade Behring, Inc. | 1998-07-09 |
| CHLAMYDIA IGG ELISA TEST SYSTEM (K962558) | Armkel, LLC | 1997-02-24 |
| ACCESS CHLAMYDIA ASSAY (K960850) | Bio-Rad Laboratories, Inc. | 1997-02-04 |
| VIDAS CHLAMYDIA BLOCKING ASSAY (K955627) | Biomerieux Vitek, Inc. | 1996-10-07 |
| IMX SELECT CHLAMYDIA (K936054) | Abbott Laboratories | 1996-05-30 |
| IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION (K940564) | Dako Diagnostics , Ltd. | 1996-01-11 |
| CHLAMYDIA OIA (K951010) | Biostar, Inc. | 1995-10-07 |
| QUICKVUE(R) CHLAMYDIA TEST (K946276) | Quidel Corp. | 1995-05-19 |
| ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (K935807) | Bio-Rad Laboratories, Inc. | 1995-05-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |