ABBOTT VERTEX ANALYZER
FDA 510(k) clearance K920559 · decided 1992-03-19
Clearance details
- K-number
- K920559
- Device name
- ABBOTT VERTEX ANALYZER
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1992-02-07
- Decision date
- 1992-03-19
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JJJ
- Device class
- 1
- Regulation number
- 862.2320
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (K962762) | Biotraces, Inc. | 1996-08-16 |
| CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER (K946387) | Capintec, Inc. | 1995-03-30 |
| GENESYS 6000 GAMMA COUNTER (K900087) | Laboratory Technologies, Inc. | 1990-07-19 |
| MATRIX(TM)-96 (K896202) | Canberra Industries, Inc. | 1990-01-02 |
| SOURCERER (K894902) | Oakfield Instruments, Ltd. | 1989-10-17 |
| SOURCERER (K884091) | John Caunt Scientific , Ltd. | 1989-02-02 |
| SAMPLE IDENTIFICATION STATION MODEL 38010 (K884269) | Icn Micromedic Systems | 1989-01-09 |
| 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (K874094) | Lkb Instruments, Inc. | 1987-11-04 |
| ISO-DATA 500 SERIES GAMMA COUNTER (K872430) | Iso-Data, Inc. | 1987-08-21 |
| ISO-DATA 100 SERIES GAMMA COUNTER (K872429) | Iso-Data, Inc. | 1987-08-21 |
| BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS (K870115) | Berthold Analytical Instruments, Inc. | 1987-03-31 |
| TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER (K862206) | Micromedic Systems | 1986-08-04 |
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 |