Gamma Biologicals, Inc.
Mchenry, IL, US
Gamma Biologicals, Inc. appears in FDA device records in Mchenry, IL. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Gamma Biologicals, Inc. between 1976 and 1986. The busiest year on record is 1976, with 8. The most recent is 1986, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 8 |
| 1979 | 1 |
| 1980 | 5 |
| 1981 | 1 |
| 1982 | 3 |
| 1983 | 1 |
| 1986 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K864207 | DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO | KTN | Substantially Equivalent | |
| K861016 | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS | KTN | Substantially Equivalent | |
| K832473 | GAMMA SLIDE TEST FOR PREGNANCY | JHJ | Substantially Equivalent | |
| K820647 | GAMMA FETAL BLEED SCREENING TEST | LIM | Substantially Equivalent | |
| K820072 | FE-CULT PLUS | KHE | Substantially Equivalent | |
| K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | KSK | Substantially Equivalent | |
| K811752 | FE-CULT PLUS | KHE | Substantially Equivalent | |
| K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | KSX | Substantially Equivalent | |
| K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | KSX | Substantially Equivalent | |
| K800658 | RST-SERIES CONTROL | KSF | Substantially Equivalent | |
| K792583 | GAMMA ARACHIS HYPOGEA LECTIN | KSI | Substantially Equivalent | |
| K792582 | POLY-LEC SYSTEM | KSI | Substantially Equivalent | |
| K790973 | LO-ION | KSG | Substantially Equivalent | |
| K760034 | TEST, STREP, LATEX SLIDE | DEM | Substantially Equivalent | |
| K760098 | REAGENT, VDRL | GMT | Substantially Equivalent | |
| K760097 | FEBRILE ANTIGENS & CONTROL SERUMS | GSZ | Substantially Equivalent | |
| K760096 | REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O | GTQ | Substantially Equivalent | |
| K760036 | TEST, LATEX SLIDE, RHEUMATOID FACTOR | DHR | Substantially Equivalent | |
| K760035 | TEST, C-REATIVE PROTEIN, LATEX SLIDE | DCK | Substantially Equivalent | |
| K760033 | TEST, ANTIBODIES FOR GRP A, LATEX SLIDE | GTZ | Substantially Equivalent | |
| K760032 | TEST, MONO., DIFFERENTIAL SLIDE | KIN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- GSZAntigens, Febrile (Weil-Felix), All Groups
- GMTAntigens, Ha, Treponema Pallidum
- GTZAntisera, All Groups, Streptococcus Spp.
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- KSFKit, Quality Control For Blood Banking Reagents
- KSILectins And Protectins
- KSGMedia, Potentiating For In Vitro Diagnostic Use
- KHEReagent, Occult Blood
- KINSlide Stainer, Contact Type
- KSKSolution, Stabilized Enzyme
- KSXSubstance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- LIMTest, Screening, For D Positive Fetal Rbc'S
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain