FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAMMADAB [125] FSH RADIOIMMUNAY KIT
K Number: K821611
·
Decision Jun 24, 1982
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
27
Review Days
22
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
- GAMMADAB [125] FSH RADIOIMMUNAY KIT
- K Number
- K821611
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinical Assays, Inc.
- Date Received
- June 2, 1982
- Decision Date
- June 24, 1982
- Product Code
- CGJ
- 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 |
|---|---|---|---|
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGJ), ordered by most recent decision date.
ONE STEP FSH MENOPAUSAL TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MOMENTS MENOPAUSE CHECK, MODEL 9113
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FSH MENOPAUSE PREDICTOR TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EARLYDETECT MENOPAUSE TEST FOR FSH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GENUA MENOPAUSE MONITOR TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Clinical Assays, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832711 | VITAMIN B12 FOLATE CA-1515-125 | Oct 4, 1983 | Substantially Equivalent |
| K832712 | FOLATE RADIOASSAY KIT CA-1562-125 | Oct 4, 1983 | Substantially Equivalent |
| K832710 | VITAMIN B12 RADIOASSAY KIT CA-1534 | Oct 4, 1983 | Substantially Equivalent |
| K823476 | GAMMADAB LH RADIO-KIT #CA-1508 | Dec 28, 1982 | Substantially Equivalent |
| K823313 | IN VITRO GAMMACOAT B-HCG RADIO. TEST | Dec 22, 1982 | Substantially Equivalent |
| K821092 | GAMMADAB[125]EGE RADIOIMMUNOASSAY IT | Jun 22, 1982 | Substantially Equivalent |
| K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | Sep 24, 1981 | Substantially Equivalent |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | May 27, 1981 | Substantially Equivalent |
| K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST | Apr 23, 1981 | Substantially Equivalent |
| K801667 | GAMMA COAT(125 I) RUBELLA ANTIBODY | Oct 23, 1980 | Substantially Equivalent |