HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST— 510(k) K041202
Substantially EquivalentW.H.P.M., Inc.
FDA 510(k) clearance K041202 for HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST, Substantially Equivalent on 2004-08-12. Applicant: W.H.P.M., Inc.. Device class: 2.
Clearance details
- Applicant
- W.H.P.M., Inc.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
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Recalls naming K041202
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041202.
Data sourced from openFDA. This site is unofficial and independent of the FDA.