FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
K Number: K970126
·
Decision Feb 25, 1997
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
49
Applicant Total
82
Review Days
42
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
- K Number
- K970126
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad Laboratories, Inc.
- Date Received
- January 14, 1997
- Decision Date
- February 25, 1997
- Product Code
- CHP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CHP | Radioimmunoassay, Estradiol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHP), ordered by most recent decision date.
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
17 B-ESTRADIOL (ELISA)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACS ESTADIOL-6 II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS ESTRADIOL ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Bio-Rad Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Feb 13, 2019 | Substantially Equivalent |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | Sep 13, 2017 | Substantially Equivalent |
| K161687 | D-10 Hemoglobin A1c Program | Oct 14, 2016 | Substantially Equivalent |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Dec 9, 2015 | Substantially Equivalent |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | Mar 24, 2015 | Substantially Equivalent |
| K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | Jun 25, 2014 | Substantially Equivalent |
| K130053 | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI | Sep 19, 2013 | Substantially Equivalent |
| K130963 | LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK | May 6, 2013 | Substantially Equivalent |
| K120504 | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK | Mar 27, 2012 | Substantially Equivalent |
| K120572 | BIOPLEX 2200 TORC IGG | Mar 26, 2012 | Substantially Equivalent |