FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CIBA CORNING ACS ESTRADIOL-6 ASSAY
K Number: K954697
·
Decision Dec 13, 1995
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
49
Applicant Total
125
Review Days
62
Basic Information
- Device Name
- CIBA CORNING ACS ESTRADIOL-6 ASSAY
- K Number
- K954697
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CIBA CORNING DIAGNOSTICS CORP.
- Date Received
- October 12, 1995
- Decision Date
- December 13, 1995
- 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.
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FDA 510(k)
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·Clinical Chemistry
Other Clearances by CIBA CORNING DIAGNOSTICS CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K962559 | ACS CORTISOL IMMUNOASSAY | Nov 5, 1996 | Substantially Equivalent |
| K963251 | CIBA CORNING ACS;180 DPD ASSAY | Oct 15, 1996 | Substantially Equivalent |
| K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | Jul 26, 1996 | Substantially Equivalent |
| K961657 | CIBA CORNING 400 SYSTEM | Jun 25, 1996 | Substantially Equivalent |
| K962021 | CIBA CORNING 348 SYSTEM | Jun 24, 1996 | Substantially Equivalent |
| K962126 | ACS CKMB II IMMUNOASSAY | Jun 21, 1996 | Substantially Equivalent |
| K962041 | ACS LH2 IMMUNOASSAY | Jun 21, 1996 | Substantially Equivalent |
| K961510 | ACS FRT4 IMMUNOASSAY | Jun 17, 1996 | Substantially Equivalent |
| K960246 | LIQUID CARDIAC MARKER 1,2,3 ASSAYED | Apr 23, 1996 | Substantially Equivalent |
| K955873 | ACS PHENYTOIN ASSAY | Mar 11, 1996 | Substantially Equivalent |