PROLACTIN RIA DIAG. KIT
FDA 510(k) clearance K771656 · decided 1977-09-22
Clearance details
- K-number
- K771656
- Device name
- PROLACTIN RIA DIAG. KIT
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1977-08-29
- Decision date
- 1977-09-22
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- JMF
- Device class
- 2
- Regulation number
- 862.1585
- 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 |
|---|---|---|
| IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) (K944933) | Diagnostic Products Corp. | 1995-03-10 |
| AMERLEX HUMAN PLACENTAL LACTOGEN (K840588) | Amersham Corp. | 1984-04-04 |
| IMMOPHASE TM HPL RADIOIMMUNOASSAY (K823292) | Corning Medical & Scientific | 1982-12-28 |
| HUMAN PLACENTAL LACTOGEN KIT (K823201) | Diagnostic Products Corp. | 1982-11-29 |
| NATAL-TEC HPL (K811370) | Armkel, LLC | 1981-05-29 |
| GESTE FOLLOW KIT DETERM. OF HPL (K802454) | Syn-Kit, Inc. | 1980-11-12 |
| CENTRIA HPL RIA (K791854) | Union Carbide Corp. | 1979-10-01 |
| HPL RIA KIT (K790919) | Technia Diagnostics , Ltd. | 1979-06-28 |
| RIA TEST, NORDICALB HPL (K782099) | Nordiclab Intl. | 1979-01-10 |
| RIALYZE HPL (RIA) (K770659) | Miles Laboratories, Inc. | 1977-05-20 |
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 |