FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHASE II B-12/FOLATE KIT
K Number: K853224
·
Decision Oct 3, 1985
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
77
Applicant Total
14
Review Days
63
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Basic Information
- Device Name
- PHASE II B-12/FOLATE KIT
- K Number
- K853224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Medical & Scientific Designs, Inc.
- Date Received
- August 1, 1985
- Decision Date
- October 3, 1985
- Product Code
- CDD
- 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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | 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 |
| 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 |
| K832499 | PHASE II TSH KIT | Sep 12, 1983 | 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 |