ABBOTT HSV EIA
FDA 510(k) clearance K843622 · decided 1985-05-20
Clearance details
- K-number
- K843622
- Device name
- ABBOTT HSV EIA
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1984-09-14
- Decision date
- 1985-05-20
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- LGC
- Device class
- 2
- Regulation number
- 866.3305
- 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 |
|---|---|---|
| HERPES GROUP IGG (K033059) | Trinity Biotech, Inc. | 2003-11-26 |
| MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 (K010878) | Diagnostic Products Corp. | 2001-04-18 |
| DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (K002262) | Diamedix Corp. | 2000-11-28 |
| HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (K000238) | Mrl Diagnostics | 2000-04-14 |
| THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K992166) | Zeus Scientific, Inc. | 1999-09-03 |
| POCKIT HSV 2 RAPID TEST (K983886) | Diagnology , Ltd. | 1999-08-19 |
| PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (K984346) | Meridian Diagnostics, Inc. | 1999-06-25 |
| HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM (K983656) | Zeus Scientific, Inc. | 1999-03-18 |
| HSV 1+2 IGG ELISA TEST (K983541) | Gull Laboratories, Inc. | 1999-02-26 |
| DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (K981306) | Diamedix Corp. | 1998-09-29 |
| HERPES GROUP IGG ELISA TEST SYSTEM (K963645) | Armkel, LLC | 1997-02-04 |
| SERAQUEST HSV IGG (K963282) | Quest Intl., Inc. | 1997-01-22 |
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 |