FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMMA ARACHIS HYPOGEA LECTIN
K Number: K792583
·
Decision Jan 16, 1980
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
3
Applicant Total
21
Review Days
33
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Basic Information
- Device Name
- GAMMA ARACHIS HYPOGEA LECTIN
- K Number
- K792583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Gamma Biologicals, Inc.
- Date Received
- December 14, 1979
- Decision Date
- January 16, 1980
- Product Code
- KSI
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KSI | Lectins And Protectins | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KSI), ordered by most recent decision date.
LECTIN-A
FDA 510(k)
FDA Class 2
·Hematology
LECTIN H
FDA 510(k)
FDA Class 2
·Hematology
POLY-LEC SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Gamma Biologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864207 | DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO | Dec 3, 1986 | Substantially Equivalent |
| 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 |