Company ยท US
Immunostics Inc.,
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2023. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KHE | Reagent, Occult Blood | 7 |
| DHR | System, Test, Rheumatoid Factor | 3 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 3 |
| GKR | System, Hemoglobin, Automated | 2 |
| KTN | System, Test, Infectious Mononucleosis | 2 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 |
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| LQN | Latex Agglutination Assay, Rubella | 1 |
| LYR | Helicobacter Pylori | 1 |
| MRG | System, Test, Vitamin D | 1 |
| OOX | Automated Occult Blood Analyzer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2023 | K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer Immunostics Inc., | MRG |
| Nov 16, 2018 | K182298 | hemochroma PLUS System Immunostics Inc., | GKR |
| Sep 8, 2017 | K163465 | hemochroma PLUS System Immunostics Inc., | GKR |
| Aug 8, 2017 | K163225 | AFIAS iFOB with AFIAS-50 Immunostics Inc., | OOX |
| Jun 14, 2017 | K171484 | hema-screen SPECIFIC Gold Immunostics Inc., | KHE |
| Jan 17, 2017 | K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test Immunostics Inc., | KHE |
| Jan 28, 2011 | K102664 | HEMA SCREEN ER Immunostics Inc., | KHE |
| Jun 6, 2006 | K060463 | HEMA SCREEN SPECIFIC IFOBT Immunostics Inc., | KHE |
| Aug 11, 2004 | K041728 | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE Immunostics Inc., | JHI |
| Jul 16, 2003 | K031490 | RUBELLACOL Immunostics Inc., | LQN |
| Dec 6, 1999 | K992759 | COLON ALERT TEST Immunostics Inc., | KHE |
| Dec 1, 1997 | K972457 | MONOCOL/LEX-IM TEST Immunostics Inc., | KTN |
| Nov 25, 1997 | K972456 | RHEUMACOL RHEUMATOID FACTOR TEST Immunostics Inc., | DHR |
| Aug 29, 1997 | K972606 | PREGNACOL PREGNANCY TEST Immunostics Inc., | JHJ |
| Apr 6, 1993 | K926569 | IMMUNO RA UNDILUTED Immunostics Co., Inc. | DHR |
| Jul 27, 1990 | K902360 | HEMA-SCREEN Immunostics Co., Inc. | KHE |
| Oct 16, 1989 | K894780 | IMMUNO/ASO Immunostics Co., Inc. | GTQ |
| Sep 28, 1988 | K883685 | IMMUNO/FEBRILE ANTIGENS Immunostics Co., Inc. | GNC |
| Aug 12, 1987 | K872910 | IMMUNO/SLE Immunostics Co., Inc. | DHC |
| Nov 13, 1986 | K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) Immunostics Co., Inc. | JHJ |
| Mar 3, 1986 | K854619 | DETECTACULT Immunostics Co., Inc. | KHE |
| Sep 3, 1985 | K853105 | IMMUNO-IM Immunostics Co., Inc. | KTN |
| Jul 12, 1984 | K842110 | SLIDE PREGNANCY TEST Immunostics Co., Inc. | JHJ |
| Feb 3, 1984 | K834391 | IMMUNO-RA Immunostics Co., Inc. | DHR |
| Feb 3, 1984 | K834390 | IMMUNO-CRP Immunostics Co., Inc. | DCN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2024 | Immunostics, Inc. Detector H. Pylori, Catalog Number IHP-30 Open, Classified |
LYR | K980798 |