FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TSHK-NN RIA KIT
K Number: K860824
·
Decision Apr 28, 1986
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
9
Review Days
55
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Basic Information
- Device Name
- TSHK-NN RIA KIT
- K Number
- K860824
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cis-Us, Inc.
- Date Received
- March 4, 1986
- Decision Date
- April 28, 1986
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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Other Clearances by Cis-Us, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951708 | ELSA-HCT | Sep 5, 1995 | Substantially Equivalent |
| K950211 | ELSA-PTH | Apr 13, 1995 | Substantially Equivalent |
| K890799 | CURIETRON 192 HIGH DOSE RATE | Oct 27, 1989 | Substantially Equivalent |
| K882449 | CESIUM 137 SOURCE, MODEL CSM-40 | Apr 14, 1989 | Substantially Equivalent |
| K871502 | PERSONNEL PROTECTIVE SHIELD | May 8, 1987 | Substantially Equivalent |
| K865027 | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C | Feb 26, 1987 | Substantially Equivalent |
| K863778 | VENTICIS II | Oct 27, 1986 | Substantially Equivalent |
| K860823 | ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT | Aug 19, 1986 | Substantially Equivalent |