ABBOTT RSV EIA
FDA 510(k) clearance K852472 · decided 1985-09-17
Clearance details
- K-number
- K852472
- Device name
- ABBOTT RSV EIA
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-06-11
- Decision date
- 1985-09-17
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- LKT
- Device class
- 1
- Regulation number
- 866.3480
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (K081928) | Diagnostic Hybrids, Inc. | 2008-12-23 |
| PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (K983336) | Diagnostic Products Corp. | 1999-03-18 |
| PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) (K943317) | Diagnostic Products Corp. | 1994-12-19 |
| RSV ANTIGEN TEST (K942173) | Neogenex | 1994-06-30 |
| RSV-MAB TEST (K912842) | Gull Laboratories, Inc. | 1991-12-09 |
| BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (K912838) | Baxter Diagnostics, Inc. | 1991-09-27 |
| BIOMERIEUX RSV DIRECT IF KIT (K912371) | Vitek Systems, Inc. | 1991-09-23 |
| RESPIRATORY SYNCYTIAL VIRUS (K894623) | Bion Ent., Ltd. | 1989-10-16 |
| RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION (K884192) | Baxter Diagnostics, Inc. | 1988-11-22 |
| ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (K882687) | Gull Laboratories, Inc. | 1988-08-30 |
| GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES (K873564) | Genetic Systems Corp. | 1987-11-20 |
| RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL (K872701) | Sita, Inc. | 1987-09-18 |
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 |