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510(k) K121565

UNI-GOLD CRYPTOSPORIDIUM by Trinity Biotech — Product Code MHJ

K121565 is an FDA 510(k) premarket notification submitted by Trinity Biotech for the device "UNI-GOLD CRYPTOSPORIDIUM". The FDA issued a decision of Substantially Equivalent on February 8, 2013. The device falls under product code MHJ (Cryptosporidium Spp.), a Class II device regulated under 21 CFR 866.3220. Trinity Biotech has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2013
Date Received
May 29, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cryptosporidium Spp.
Device Class
Class II
Regulation Number
866.3220
Review Panel
MI
Submission Type

Other clearances by Trinity Biotech

  • K172254 — Lyme B. burgdorferi (IgM) MarStripe Test (October 23, 2017)
  • K163095 — Lyme B. burgdorferi (IgG) MarStripe Test (February 1, 2017)
  • K120001 — UNIGOLD GIARDIA (March 1, 2013)
  • K083896 — DESTINY MAX COAGULATION ANALYZER (July 2, 2009)
  • K033059 — HERPES GROUP IGG (November 26, 2003)
  • K014233 — CAPTIAM SYPHILIS-G ASSAY (January 24, 2002)
  • K011709 — UNI-GOLD STREP A TEST KIT (November 8, 2001)
  • K001525 — CAPTIA SYPHILIS-G ELISA TEST SYSTEM (November 29, 2000)
  • K991697 — UNI-GOLD H. PYLORI (December 21, 1999)
  • K982373 — UNI-GOLD STREP A TEST KIT (February 11, 1999)

Other clearances for product code MHJ

  • K171078 — TRI-COMBO PARASITE SCREEN (July 10, 2017)
  • K051929 — GIARDIA/CRYPTOSPORIDIUM CHEK (November 17, 2005)
  • K052932 — CRYPTOSPORIDIUM II (November 4, 2005)
  • K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (November 14, 2003)
  • K031059 — IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 (July 10, 2003)
  • K982764 — PREMIER CRYPTOSPORIDIUM (December 3, 1998)
  • K982709 — MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY (September 3, 1998)
  • K980354 — CRYPTOSPORIDIUM TEST (May 18, 1998)
  • K955852 — CRYPTO-CEL IF TEST (August 5, 1996)
  • K955755 — TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS (July 11, 1996)

FDA data resources