Company ยท US
Gamma Biologicals, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1986. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KHE | Reagent, Occult Blood | 2 |
| KSI | Lectins And Protectins | 2 |
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use | 2 |
| KTN | System, Test, Infectious Mononucleosis | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| GMT | Antigens, Ha, Treponema Pallidum | 1 |
| GSZ | Antigens, Febrile (Weil-Felix), All Groups | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 |
| KIN | Slide Stainer, Contact Type | 1 |
| KSF | Kit, Quality Control For Blood Banking Reagents | 1 |
| KSG | Media, Potentiating For In Vitro Diagnostic Use | 1 |
| KSK | Solution, Stabilized Enzyme | 1 |
| LIM | Test, Screening, For D Positive Fetal Rbc'S | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 3, 1986 | K864207 | DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO Gamma Biologicals, Inc. | KTN |
| Apr 18, 1986 | K861016 | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS Gamma Biologicals, Inc. | KTN |
| Aug 16, 1983 | K832473 | GAMMA SLIDE TEST FOR PREGNANCY Gamma Biologicals, Inc. | JHJ |
| May 12, 1982 | K820647 | GAMMA FETAL BLEED SCREENING TEST Gamma Biologicals, Inc. | LIM |
| Mar 4, 1982 | K820072 | FE-CULT PLUS Gamma Biologicals, Inc. | KHE |
| Mar 4, 1982 | K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION Gamma Biologicals, Inc. | KSK |
| Nov 2, 1981 | K811752 | FE-CULT PLUS Gamma Biologicals, Inc. | KHE |
| Nov 12, 1980 | K802534 | GAMMA PI BLOOD GROUP SUBSTANCE Gamma Biologicals, Inc. | KSX |
| Nov 12, 1980 | K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE Gamma Biologicals, Inc. | KSX |
| Apr 16, 1980 | K800658 | RST-SERIES CONTROL Gamma Biologicals, Inc. | KSF |
| Jan 16, 1980 | K792583 | GAMMA ARACHIS HYPOGEA LECTIN Gamma Biologicals, Inc. | KSI |
| Jan 16, 1980 | K792582 | POLY-LEC SYSTEM Gamma Biologicals, Inc. | KSI |
| Jun 15, 1979 | K790973 | LO-ION Gamma Biologicals, Inc. | KSG |
| Aug 11, 1976 | K760034 | TEST, STREP, LATEX SLIDE Gamma Biologicals, Inc. | DEM |
| Aug 3, 1976 | K760098 | REAGENT, VDRL Gamma Biologicals, Inc. | GMT |
| Aug 3, 1976 | K760097 | FEBRILE ANTIGENS & CONTROL SERUMS Gamma Biologicals, Inc. | GSZ |
| Aug 3, 1976 | K760096 | REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O Gamma Biologicals, Inc. | GTQ |
| Aug 3, 1976 | K760036 | TEST, LATEX SLIDE, RHEUMATOID FACTOR Gamma Biologicals, Inc. | DHR |
| Aug 3, 1976 | K760035 | TEST, C-REATIVE PROTEIN, LATEX SLIDE Gamma Biologicals, Inc. | DCK |
| Aug 3, 1976 | K760033 | TEST, ANTIBODIES FOR GRP A, LATEX SLIDE Gamma Biologicals, Inc. | GTZ |
| Aug 3, 1976 | K760032 | TEST, MONO., DIFFERENTIAL SLIDE Gamma Biologicals, Inc. | KIN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||