Panels › Hematology › Product code KHE · Class 2
Reagent, Occult Blood
Regulation 864.6550
0510(k)s in 12 months (97 all time)
2recalls in 12 months (19 all time)
16recalls that name a 510(k)
Top companies in KHE
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 12 | 2 |
| Immunostics Co., Inc. | 7 | 0 |
| Alere North Americal | 0 | 6 |
| Enterix, Inc. | 3 | 3 |
| Smithkline Diagnostics, Inc. | 4 | 0 |
| Aerscher Diagnostics | 3 | 0 |
| Alfa Scientific Designs, Inc. | 3 | 0 |
| Polymedco, Inc. | 1 | 2 |
| Propper Mfg. Co., Inc. | 3 | 0 |
| Ameritek USA, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Fecal Occult Blood Test Open, Classified |
KHE | None listed |
| Nov 28, 2025 | Enterix, Inc. InSure ONE Fecal Immunochemical Test. Labeled as follows:
1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010.
2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025.
3. InSure ONE P Open, Classified |
KHE | K170548 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487.
b. MMS - IMMUNOSTICS INC McKess Open, Classified |
KHE | None listed |
| Oct 8, 2020 | Enterix, Inc. InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01. Terminated |
KHE | K170548 |
| Feb 27, 2019 | Cypress Medical Products LLC McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50,
178CK30 Terminated |
KHE | K041202 |
| Sep 24, 2018 | Roche Diagnostics Corporation Roche Diagnostics URISYS 1100 Urine Analyzer
Part Number: 03617556001
Product Usage:
The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results Terminated |
KHE | K033548 |
| Aug 8, 2018 | Helena Laboratories, Corp. ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. Open, Classified |
KHE | K882799 |
| Aug 8, 2018 | Helena Laboratories, Corp. ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. Open, Classified |
KHE | K882799 |
| Sep 13, 2013 | Assuramed Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mi Terminated |
KHE | K080812 |
| Aug 22, 2013 | Beckman Coulter Inc. Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. Terminated |
KHE | K080812 |
| Apr 4, 2013 | Polymedco, Inc Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR.
For the rapid, qualitative detection of human hemoglobin in feces. Terminated |
KHE | None listed |
| Apr 4, 2013 | Polymedco, Inc Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50.
For the rapid, qualitative detection of human hemoglobin in feces. Terminated |
KHE | K041297 |
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview - Clearview iFOB Return Mailer(accessory)
Product Part Number:
8117KCV
Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in hu Terminated |
KHE | K063693 |
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory)
Product Part Number:
8116KCV
Intended Use: Immunochemical device intended for the qualitative detection if fecal occult bloo Terminated |
KHE | K063693 |
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test)
Immunochemical Fecal Occult Blood Cassette Test
Product Part Number:
8115KCV (25 Test Kit ),
Intended Use: Immunochemical device i Terminated |
KHE | K063693 |
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (25 Test)
Immunochemical Fecal Occult Blood Cassette Test
Product Part Number:
8114KCV (25 Test Kit ),
Intended Use: Immunochemical device Terminated |
KHE | K063693 |
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood Cassette Test
Product Part Number:
8112KCV (5 Test Kit ),
Intended Use: Immunochemical device intended for the qualit Terminated |
KHE | K073431 |
| Apr 28, 2011 | Alere North Americal Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test
Product Part Number:
8111KCV (30 Test Kit ),
Intended Use: Immunochemical device intended for the qualitative Terminated |
KHE | K073431 |
| Dec 29, 2008 | Enterix, Inc. INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits.
Terminated |
KHE | K060930 |
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