FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHASE II TSH KIT
K Number: K832499
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
14
Review Days
47
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Basic Information
- Device Name
- PHASE II TSH KIT
- K Number
- K832499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Medical & Scientific Designs, Inc.
- Date Received
- July 27, 1983
- Decision Date
- September 12, 1983
- 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 Medical & Scientific Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862960 | PHASE II FERRITIN RADIOIMMUNOASSAY KIT | Aug 27, 1986 | Substantially Equivalent |
| K853224 | PHASE II B-12/FOLATE KIT | Oct 3, 1985 | Substantially Equivalent |
| K840901 | PHASE II FREE T4 KIT | Apr 25, 1984 | Substantially Equivalent |
| K840328 | PHASE II HCG KIT | Apr 19, 1984 | Substantially Equivalent |
| K834219 | PHASE II CORTISOL KIT | Feb 4, 1984 | Substantially Equivalent |
| K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | Jan 24, 1984 | Substantially Equivalent |
| K832209 | KINETI COUNT 24 GAMMA COUNTER | Aug 24, 1983 | Substantially Equivalent |
| K832210 | GAMMA PHOTON GAMMA COUNTER | Aug 24, 1983 | Substantially Equivalent |
| K831064 | PHASE II T3 RADIOIMMUNOASSAY KIT | May 9, 1983 | Substantially Equivalent |
| K830900 | UPTAKE T3 RADIOIMMUNOASSAY KIT | Apr 18, 1983 | Substantially Equivalent |