FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
K Number: K844767
·
Decision Feb 1, 1985
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
15
Review Days
56
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
- RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
- K Number
- K844767
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biotecx Laboratories, Inc.
- Date Received
- December 7, 1984
- Decision Date
- February 1, 1985
- Product Code
- CGI
- 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 |
|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGI), ordered by most recent decision date.
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COAT-A-COUNT FREE ESTRIOL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
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 |
| K851540 | ESTRADIOL DIRECT RIA KIT | Jun 6, 1985 | Substantially Equivalent |