FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED
K Number: K860998
·
Decision Apr 3, 1986
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
125
Review Days
16
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Basic Information
- Device Name
- GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED
- K Number
- K860998
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ciba Corning Diagnostics Corp.
- Date Received
- March 18, 1986
- Decision Date
- April 3, 1986
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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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 |