FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COBAS CORE FSH EIA
K Number: K930304
·
Decision Sep 21, 1993
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
296
Review Days
243
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Basic Information
- Device Name
- COBAS CORE FSH EIA
- K Number
- K930304
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- January 21, 1993
- Decision Date
- September 21, 1993
- 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)
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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 Roche Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | May 3, 1999 | Substantially Equivalent |
| K983702 | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES | Feb 11, 1999 | Substantially Equivalent |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | Feb 10, 1999 | Substantially Equivalent |
| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | Dec 15, 1998 | Substantially Equivalent |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | Dec 15, 1998 | Substantially Equivalent |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | Dec 11, 1998 | Substantially Equivalent |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | Dec 11, 1998 | Substantially Equivalent |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | Dec 11, 1998 | Substantially Equivalent |
| K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | Dec 11, 1998 | Substantially Equivalent |
| K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | Dec 11, 1998 | Substantially Equivalent |