ACCU-CULT FECAL OCCULT BLOOD TEST— 510(k) K840904
Substantially EquivalentApplied Medical Devices, Inc.
FDA 510(k) clearance K840904 for ACCU-CULT FECAL OCCULT BLOOD TEST, Substantially Equivalent on 1984-08-16. Applicant: Applied Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Applied Medical Devices, 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
- Mchenry, IL, US
Recent devices under product code KHE
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