Product code MHJ— Microbiology

FDA has cleared 15 devices under product code MHJ between 1991 and 2017, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20171 clearance
• 20131 clearance
• 20052 clearances
• 20032 clearances
• 19983 clearances
• 19963 clearances
• 19941 clearance
• 19921 clearance
• 19911 clearance

• Techlab, Inc.5 clearances
• Lmd Laboratories2 clearances
• Trinity Biotech1 clearance
• Trend Scientific, Inc.1 clearance
• Remel, Inc.1 clearance
• Meridian Diagnostics, Inc.1 clearance
• Ivd Research, Inc.1 clearance
• Alexon - Trend, Inc.1 clearance
• Alexon, Inc.1 clearance
• Alexon Biomedical, Inc.1 clearance

• K171078 — TRI-COMBO PARASITE SCREENTechlab, Inc.·2017-07-10
• K121565 — UNI-GOLD CRYPTOSPORIDIUMTrinity Biotech·2013-02-08
• K051929 — GIARDIA/CRYPTOSPORIDIUM CHEKTechlab, Inc.·2005-11-17
• K052932 — CRYPTOSPORIDIUM IITechlab, Inc.·2005-11-04
• K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020Remel, Inc.·2003-11-14
• K031059 — IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96Ivd Research, Inc.·2003-07-10
• K982764 — PREMIER CRYPTOSPORIDIUMMeridian Diagnostics, Inc.·1998-12-03
• K982709 — MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAYAlexon - Trend, Inc.·1998-09-03
• K980354 — CRYPTOSPORIDIUM TESTTechlab, Inc.·1998-05-18
• K955852 — CRYPTO-CEL IF TESTTechlab, Inc.·1996-08-05
• K955755 — TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMSTrend Scientific, Inc.·1996-07-11
• K955345 — LMD CRYPTOSPORIDIUM ANTIGEN DETECTIONLmd Laboratories·1996-06-07
• K936191 — PROSPECT CRYPTOSPORIDIUM RAPID ASSAYAlexon Biomedical, Inc.·1994-11-17
• K912242 — PROSPECT(TM/CRYPTOSPORIDIUMAlexon, Inc.·1992-03-23
• K905598 — CRYPTOSPORIDIUM ANTIGEN DETECTIONLmd Laboratories·1991-09-05