Immunostics Inc.,
Immunostics Inc., holds FDA 510(k) medical device clearances, first cleared 1997, most recent 2023, with 1 FDA device recall on record.
Top product codes for Immunostics Inc.,
FDA recalls by Immunostics Inc.,
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Immunostics Inc.,
- K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer
- K182298 — hemochroma PLUS System
- K163465 — hemochroma PLUS System
- K163225 — AFIAS iFOB with AFIAS-50
- K171484 — hema-screen SPECIFIC Gold
- K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
- K102664 — HEMA SCREEN ER
- K060463 — HEMA SCREEN SPECIFIC IFOBT
- K041728 — HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
- K031490 — RUBELLACOL
- K992759 — COLON ALERT TEST
- K972457 — MONOCOL/LEX-IM TEST
- K972456 — RHEUMACOL RHEUMATOID FACTOR TEST
- K972606 — PREGNACOL PREGNANCY TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.