Atlas FDA

POLYMEDCO OC LIGHT FOBT TEST

FDA 510(k) clearance K041297 · decided 2004-08-12

Clearance details

K-number
K041297
Device name
POLYMEDCO OC LIGHT FOBT TEST
Applicant
Polymedco, Inc.
Decision
Substantially Equivalent
Date received
2004-05-14
Decision date
2004-08-12
Days to decision
90 days
Clearance type
Traditional
Product code
KHE
Device class
2
Regulation number
864.6550
Medical specialty
Hematology
Advisory committee
Hematology
Location
Cortlandt Manor, NY, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Polymedco

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Instant-view-PLUS immunochemical Fecal Occult Blood Test (K173212)Alfa Scientific Designs, Inc.2018-02-15
InSure ONE (K170548)Enterix, Inc.2017-10-05
hema-screen SPECIFIC Gold (K171484)Immunostics Inc.,2017-06-14
Wondfo One Step Fecal Occult Blood (FOB) Test (K162333)Guangzhou Wondfo Biotech Co., Ltd.2017-05-14
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (K163554)Immunostics Inc.,2017-01-17
OC-Light S FIT (K143325)Eiken Chemical Co., Ltd.2015-08-20
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT (K121397)SEKISUI Diagnostics, LLC2012-12-28
IND ONE STEP OCCULT BLOOD (FOB) TEST (K113506)Ind Diagnostics, Inc.2012-12-19
FOB ONE STEP RAPID TEST (K110309)Orient Gene Biotech2011-09-14
HEMA SCREEN ER (K102664)Immunostics Inc.,2011-01-28
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 (K100031)Ind Diagnostic, Inc.2010-07-19
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST (K100817)Princeton BioMeditech Corp.2010-07-01

Recalls involving this device

RecordFirmDate
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, q recall (Z-1059-2013)Polymedco, Inc2013-04-04