A-JUST TURBIDITY METER
FDA 510(k) clearance K851234 · decided 1985-04-29
Clearance details
- K-number
- K851234
- Device name
- A-JUST TURBIDITY METER
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-03-26
- Decision date
- 1985-04-29
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- JQX
- Device class
- 1
- Regulation number
- 862.2700
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irving, TX, 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 |
|---|---|---|
| IMMAGE IMMUNOCHEMISTRY SYSTEM (K962294) | Beckman Instruments, Inc. | 1996-08-21 |
| ARRAY(R) 360 (K922273) | Beckman Instruments, Inc. | 1992-08-19 |
| QMS(TM) - THEOPHYLLINE (K885263) | Seradyn, Inc. | 1989-03-28 |
| TDX ANALYZER W/NEPHELOMETRY CAROUSEL (K851253) | Abbott Laboratories | 1985-04-30 |
| ALBUMIN NEPHELOMETRIC ASSAY (K801362) | J.T. Baker Chemical Co. | 1980-07-21 |
| J.T. BAKER NEPHELOMETER (K801089) | J.T. Baker Chemical Co. | 1980-05-28 |
| BIOVATION NEPHELOMETER (K792045) | Biovation, Inc. | 1979-10-30 |
| NEPHELOMETER, MIC-2000 LASER (K790103) | Dynatech Corp. | 1979-03-12 |
| RAD-291 (K781554) | Organon, Inc. | 1978-10-11 |
| ANTIBIOTIC NEPHELOMETER (K781644) | Biovation, Inc. | 1978-10-03 |
| NEPHELOMETER (K780251) | Kallestad Laboratories, Inc. | 1978-04-06 |
| LASER IMMUNONEPHELOMETRIC ANALYZER (K772361) | G.D. Searle and Co. | 1978-01-30 |
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 |