FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESTRADIOL KIT BY RIA
K Number: K820329
·
Decision Mar 4, 1982
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
49
Applicant Total
18
Review Days
24
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 KIT BY RIA
- K Number
- K820329
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immuchem Corp.
- Date Received
- February 8, 1982
- Decision Date
- March 4, 1982
- 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 Immuchem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883726 | THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL | Dec 15, 1988 | Substantially Equivalent |
| K871317 | FOLLICLE STIMULATING HORMONE (HFSH) | May 20, 1987 | Substantially Equivalent |
| K871542 | HPROLACTIN KIT | May 14, 1987 | Substantially Equivalent |
| K865071 | THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT | Mar 13, 1987 | Substantially Equivalent |
| K864144 | LUTEINIZING HORMONE (LH-IRMA) RIA KIT | Nov 24, 1986 | Substantially Equivalent |
| K860559 | ANDROSTENEDIONE 125I KIT BY RIA | Mar 14, 1986 | Substantially Equivalent |
| K854094 | IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS | Feb 28, 1986 | Substantially Equivalent |
| K830962 | IMMUCHEM COVALENT-COAT RIA KIT | May 4, 1983 | Substantially Equivalent |
| K822509 | COVALENT COAT RIA KIT | Sep 28, 1982 | Substantially Equivalent |
| K822140 | IMMUCHEM COVALENT-COAT | Aug 5, 1982 | Substantially Equivalent |