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510(k) K171484

hema-screen SPECIFIC Gold by Immunostics Inc., — Product Code KHE

K171484 is an FDA 510(k) premarket notification submitted by Immunostics Inc., for the device "hema-screen SPECIFIC Gold". The FDA issued a decision of Substantially Equivalent on June 14, 2017. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Immunostics Inc., has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2017
Date Received
May 22, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Occult Blood
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

Other clearances by Immunostics Inc.,

  • K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer (September 22, 2023)
  • K182298 — hemochroma PLUS System (November 16, 2018)
  • K163465 — hemochroma PLUS System (September 8, 2017)
  • K163225 — AFIAS iFOB with AFIAS-50 (August 8, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K102664 — HEMA SCREEN ER (January 28, 2011)
  • K060463 — HEMA SCREEN SPECIFIC IFOBT (June 6, 2006)
  • K041728 — HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE (August 11, 2004)
  • K031490 — RUBELLACOL (July 16, 2003)
  • K992759 — COLON ALERT TEST (December 6, 1999)

Other clearances for product code KHE

  • K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test (February 15, 2018)
  • K170548 — InSure ONE (October 5, 2017)
  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K143325 — OC-Light S FIT (August 20, 2015)
  • K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)
  • K113506 — IND ONE STEP OCCULT BLOOD (FOB) TEST (December 19, 2012)
  • K110309 — FOB ONE STEP RAPID TEST (September 14, 2011)
  • K102664 — HEMA SCREEN ER (January 28, 2011)
  • K100031 — IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 (July 19, 2010)

FDA data resources