ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
FDA 510(k) clearance K844914 · decided 1985-02-12
Clearance details
- K-number
- K844914
- Device name
- ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1984-12-18
- Decision date
- 1985-02-12
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- JHJ
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| PREGNACOL PREGNANCY TEST (K972606) | Immunostics Inc., | 1997-08-29 |
| IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (K921968) | Tech-Co, Inc. | 1996-06-28 |
| SAS(TM) DIRECT MONOCLONAL HCG (K935863) | Sa Scientific, Inc. | 1994-02-24 |
| ACCUTEX BETA-HCG TEST (K926112) | J.S. Medical Assoc. | 1993-07-28 |
| SAS(TM) MONOCLONAL HCG-SLIDE (K930609) | Sa Scientific, Inc. | 1993-03-29 |
| DIRECT PREGNANCY TEST (K920716) | Tech-Co, Inc. | 1992-03-24 |
| CLEARVIEW HCG (K910946) | Unipath , Ltd. | 1991-04-01 |
| PREGNOSPIA II (K881435) | Organon Teknika Corp. | 1988-05-27 |
| PREGNANCY (HCG) CARD & LIQUID TEST (K880163) | Ampcor, Inc. | 1988-05-17 |
| PREGNANCY BETA-HCG CARD & LIQUID TEST (K880478) | Ampcor, Inc. | 1988-04-28 |
| HCG-NOSTICK (K880328) | Organon Teknika Corp. | 1988-03-15 |
| V-TREND BETA-HCG DRY-SPOT TEST (K875262) | Texas Immunology, Inc. | 1988-02-02 |
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 |