MHJ · Class II · 21 CFR 866.3220

FDA Product Code MHJ: Cryptosporidium Spp.

Leading manufacturers include Techlab, Inc., Remel, Inc. and Trinity Biotech.

15
Total
15
Cleared
168d
Avg days
1991
Since

FDA 510(k) Cleared Cryptosporidium Spp. Devices (Product Code MHJ)

15 devices
1–15 of 15
Cleared Jul 10, 2017
TRI-COMBO PARASITE SCREEN
K171078
Techlab, Inc.
Microbiology · 90d
Cleared Feb 08, 2013
UNI-GOLD CRYPTOSPORIDIUM
K121565
Trinity Biotech
Microbiology · 255d
Cleared Nov 17, 2005
GIARDIA/CRYPTOSPORIDIUM CHEK
K051929
Techlab, Inc.
Microbiology · 127d
Cleared Nov 04, 2005
CRYPTOSPORIDIUM II
K052932
Techlab, Inc.
Microbiology · 16d
Cleared Nov 14, 2003
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965
Remel, Inc.
Microbiology · 141d
Cleared Dec 03, 1998
PREMIER CRYPTOSPORIDIUM
K982764
Meridian Diagnostics, Inc.
Microbiology · 119d
Cleared Sep 03, 1998
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
K982709
Alexon - Trend, Inc.
Microbiology · 30d
Cleared May 18, 1998
CRYPTOSPORIDIUM TEST
K980354
Techlab, Inc.
Microbiology · 109d
Cleared Aug 05, 1996
CRYPTO-CEL IF TEST
K955852
Techlab, Inc.
Microbiology · 223d
Cleared Jul 11, 1996
TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
K955755
Trend Scientific, Inc.
Microbiology · 204d
Cleared Jun 07, 1996
LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
K955345
Lmd Laboratories
Microbiology · 199d

About Product Code MHJ - Regulatory Context