FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RST-SERIES CONTROL
K Number: K800658
·
Decision Apr 16, 1980
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
11
Applicant Total
21
Review Days
21
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Basic Information
- Device Name
- RST-SERIES CONTROL
- K Number
- K800658
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9650
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Gamma Biologicals, Inc.
- Date Received
- March 26, 1980
- Decision Date
- April 16, 1980
- Product Code
- KSF
- Advisory Committee
- Hematology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| KSF | Kit, Quality Control For Blood Banking Reagents | FDA class 2 | Hematology |
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TEST CELLS
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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 |
| K792582 | POLY-LEC SYSTEM | Jan 16, 1980 | Substantially Equivalent |