FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THYROID STIMULATING HORMONE-EIA-XT
K Number: K896867
·
Decision Feb 23, 1990
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
15
Review Days
79
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Basic Information
- Device Name
- THYROID STIMULATING HORMONE-EIA-XT
- K Number
- K896867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- In Vitro Diagnostics, Inc.
- Date Received
- December 6, 1989
- Decision Date
- February 23, 1990
- 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 In Vitro Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896863 | DIGOXIN-EIA-XT | Feb 13, 1990 | Substantially Equivalent |
| K896866 | LUTEINIZING HORMONE-EIA-XT | Feb 13, 1990 | Substantially Equivalent |
| K896865 | VITRO T4-EIA-XT | Jan 30, 1990 | Substantially Equivalent |
| K896925 | T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT | Jan 18, 1990 | Substantially Equivalent |
| K896864 | FOLLICLE STIMULATING HORMONE-EIA-XT | Jan 11, 1990 | Substantially Equivalent |
| K873832 | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | Nov 23, 1987 | Substantially Equivalent |
| K871182 | FLAME PHOTOMETER STANDARD #60081 120 NA/2K | May 28, 1987 | Substantially Equivalent |
| K871183 | FLAME PHOTOMETER STANDARD #60082 140 NA/5K | May 28, 1987 | Substantially Equivalent |
| K871188 | LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 | May 28, 1987 | Substantially Equivalent |
| K871185 | LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 | May 28, 1987 | Substantially Equivalent |