BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
FDA 510(k) clearance K961792 · decided 1996-08-21
Clearance details
- K-number
- K961792
- Device name
- BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
- Applicant
- Biocircuits Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-09
- Decision date
- 1996-08-21
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- DHA
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biocircuits Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|
| VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581) | Ortho Clinical Diagnostics | 2024-05-08 |
| iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (K223690) | Shenzhen Yhlo Biotech Co., Ltd. | 2023-12-11 |
| Alinity i Total ß-hCG Reagent Kit, GLP systems Track (K230937) | Abbott Laboratories | 2023-06-05 |
| Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790) | Abbott Laboratories | 2023-05-19 |
| Access Total ßhCG (5th IS) (K221990) | Beckman Coulter, Inc. | 2022-12-27 |
| Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer (K212221) | Diazyme Laboratories, Inc. | 2021-12-13 |
| Elecsys HCG STAT (K203227) | Roche Diagnostics | 2021-08-18 |
| ADVIA Centaur® Total hCG assay (K200210) | Siemens Healthcare Diagnostics, Inc. | 2021-07-13 |
| MAGLUMI 2000 HCG/ß-HCG (K192547) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020-01-17 |
| Atellica IM Total hCG (ThCG) (K192790) | Siemens Healthcare Diagnostics, Inc. | 2019-10-30 |
| Alinity i Total ß-hCG Reagent Kit, Alinity i System (K170317) | Abbott Laboratories | 2017-10-23 |
| Diazyme DZ-Lite Total beta-hCG Test System (K163418) | Diazyme Laboratories | 2017-08-18 |
Recalls involving this device
No recalls on record reference this clearance.