FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
K Number: K864207
·
Decision Dec 3, 1986
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
21
Review Days
37
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Basic Information
- Device Name
- DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
- K Number
- K864207
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Gamma Biologicals, Inc.
- Date Received
- October 27, 1986
- Decision Date
- December 3, 1986
- Product Code
- KTN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTN), ordered by most recent decision date.
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Other Clearances by Gamma Biologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861016 | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS | Apr 18, 1986 | Substantially Equivalent |
| K832473 | GAMMA SLIDE TEST FOR PREGNANCY | Aug 16, 1983 | Substantially Equivalent |
| K820647 | GAMMA FETAL BLEED SCREENING TEST | May 12, 1982 | Substantially Equivalent |
| K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | Mar 4, 1982 | Substantially Equivalent |
| K820072 | FE-CULT PLUS | Mar 4, 1982 | Substantially Equivalent |
| K811752 | FE-CULT PLUS | Nov 2, 1981 | Substantially Equivalent |
| K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | Nov 12, 1980 | Substantially Equivalent |
| K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | Nov 12, 1980 | Substantially Equivalent |
| K800658 | RST-SERIES CONTROL | Apr 16, 1980 | Substantially Equivalent |
| K792582 | POLY-LEC SYSTEM | Jan 16, 1980 | Substantially Equivalent |