FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESTRADIOL DIRECT RIA KIT
K Number: K851540
·
Decision Jun 6, 1985
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
49
Applicant Total
15
Review Days
51
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
- ESTRADIOL DIRECT RIA KIT
- K Number
- K851540
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biotecx Laboratories, Inc.
- Date Received
- April 16, 1985
- Decision Date
- June 6, 1985
- 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
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Biotecx Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982298 | OPTICOAT T4 EIA KIT | Feb 3, 1999 | Substantially Equivalent |
| K981824 | OPTICOAT T3 EIA KIT | Dec 22, 1998 | Substantially Equivalent |
| K895407 | CORTISOL CLASP-BEAD EIA KIT | Oct 19, 1989 | Substantially Equivalent |
| K893620 | T3 CLASP-BEAD EIA KIT | Aug 11, 1989 | Substantially Equivalent |
| K892853 | T4 CLASP-BEAD EIA KIT | May 22, 1989 | Substantially Equivalent |
| K883765 | TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE | Oct 31, 1988 | Substantially Equivalent |
| K871211 | PROGESTERONE CLASP RADIOIMMUNOASSAY KIT | Apr 13, 1987 | Substantially Equivalent |
| K863188 | HPL RIA KIT | Sep 25, 1986 | Substantially Equivalent |
| K854876 | ALDOSTERONE DIRECT RIA KIT | Mar 17, 1986 | Substantially Equivalent |
| K844767 | RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO | Feb 1, 1985 | Substantially Equivalent |