FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA
K Number: K862439
·
Decision Aug 19, 1986
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
20
Review Days
54
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Basic Information
- Device Name
- SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA
- K Number
- K862439
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Date Received
- June 26, 1986
- Decision Date
- August 19, 1986
- 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
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MOMENTS MENOPAUSE CHECK, MODEL 9113
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FSH MENOPAUSE PREDICTOR TEST
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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 Boots-Celltech Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871877 | IDEIA HERPES SIMPLEX VIRUS TEST | Nov 17, 1989 | Substantially Equivalent |
| K880799 | MODIFIED IDEIA CHLAMYDIA TEST | Dec 8, 1988 | Substantially Equivalent |
| K880758 | SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY | Apr 18, 1988 | Substantially Equivalent |
| K874875 | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) | Mar 24, 1988 | Substantially Equivalent |
| K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | Feb 24, 1988 | Substantially Equivalent |
| K872843 | OVEIA (TM) DUAL ANALYTE | Feb 2, 1988 | Substantially Equivalent |
| K873625 | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) | Oct 20, 1987 | Substantially Equivalent |
| K872056 | MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST | Jun 15, 1987 | Substantially Equivalent |
| K870602 | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST | May 8, 1987 | Substantially Equivalent |
| K864998 | IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | Apr 20, 1987 | Substantially Equivalent |